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A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Odanacatib
Odanacatib
Odanacatib
Odanacatib
Vitamin D3
Calcium Carbonate
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Postmenopausal for 5 or more years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy Bone mineral density T-score at the hip or spine of -2.0 or less Spinal anatomy suitable for dual-energy x-ray absorptiometry (DXA). At the lumbar spine, there is no evidence of vertebral fracture in at least 3 vertebrae in the L1 to L4 region on baseline spine films. (Significant scoliosis, bony trauma, degenerative joint disease, and sequelae of orthopedic procedures that result in anatomy that is unsuitable for accurate bone densitometry must be absent from the lumbar spine.) At least one hip must be evaluable by DXA (e.g., contain no hardware from orthopedic procedures) In a state of general health allowing for successful completion of the trial Agreement to not use any medications to treat osteoporosis during the study Exclusion Criteria: History of prior osteoporotic fracture (unless declined treatment with or was ineligible for osteoporosis therapy) Past treatment with osteoporosis medications, steroids, hormone replacement, as well as various other medications that affect bone may be exclusionary. (Different exclusion criteria apply to each bone active drug. For example, any prior use of intravenous (IV) bisphosphonates is not permitted. By contrast, prior use of hormone replacement for several years is permitted if it has not occurred within the past 6 months. Please ask the study doctor for details) Significant clinical or laboratory abnormalities at the screening visit for the study that, in the opinion of the investigator, could complicate interpretation of the study results or pose additional risk to the patient (for example, patients who are non-ambulatory should be excluded for this reason)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo

    Odanacatib 3 mg

    Odanacatib 10 mg

    Odanacatib 25 mg

    Odanacatib 50 mg

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
    Percentage change in lumbar spine BMD (relative to baseline) at 12 Months.
    Percentage Change From Baseline in Lumbar Spine BMD at 24 Months
    Percentage change in lumbar spine BMD (relative to baseline) at 24 Months.
    Percentage Change From Baseline in Lumbar Spine BMD at 36 Months
    Percentage change in lumbar spine BMD (relative to baseline) at 36 months
    Percentage Change From Baseline in Lumbar Spine BMD at 60 Months
    Percentage change from baseline in lumbar spine BMD at 60 months.
    Percentage Change From Baseline in Lumbar Spine BMD at 120 Months
    Percentage change from baseline in lumbar spine BMD at 120 Months.
    Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment Years 6-10 (60 Months)
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
    Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Years 6-10 (60 Months)
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.

    Secondary Outcome Measures

    Percentage Change From Baseline in Total Hip BMD at 12 Months
    Percentage change in total hip BMD (relative to baseline) at 12 months
    Percentage Change From Baseline in Femoral Neck BMD at 12 Months
    Percentage change in femoral neck BMD (relative to baseline) at 12 months
    Percentage Change From Baseline in Trochanter BMD at 12 Months
    Percentage change in trochanter BMD (relative to baseline) at 12 months
    Percentage Change From Baseline in Total Body BMD at 12 Months
    Percentage change in total body BMD (relative to baseline) at 12 months
    Percentage Change From Baseline in Distal Forearm BMD at 12 Months
    Percentage change in distal forearm BMD (relative to baseline) at 12 months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 12 Months
    Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u-NTx)) at 12 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 12 Months
    Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) at 12 Months.
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 12 Months
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 12 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 12 Months
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)), at 12 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 12 Months
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen (s-P1NP) (relative to baseline) at 12 Months
    Percentage Change From Baseline in Total Hip Bone Mineral Density at 24 Months
    Percentage change in total hip Bone Mineral Density (relative to baseline) at 24 Months
    Percentage Change From Baseline in Femoral Neck BMD at 24 Months
    Percentage change in femoral neck Bone Mineral Density (relative to baseline) at 24 Months
    Percentage Change From Baseline in Trochanter BMD at 24 Months
    Percentage change from baseline in trochanter BMD (relative to baseline) at 24 Months
    Percentage Change From Baseline in Total Body BMD at 24 Months
    Percentage change in total body BMD (relative to baseline) at 24 Months
    Percentage Change From Baseline in Distal Forearm BMD at 24 Months
    Percentage change in distal forearm BMD (relative to baseline) at 24 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 24 Months
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (u-NTx) (relative to baseline) at 24 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 24 Months
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) (relative to baseline) at 24 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 24 Months
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 24 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 24 Months
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)) (relative to baseline) at 24 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 24 Months
    Back-transformation (geometric mean) of the least squares mean of the log-values percentage change from baseline in biochemical marker of bone turnover (s-P1NP) (relative to baseline) at 24 months
    Percentage Change From Baseline in Total Hip BMD at 36 Months
    Percentage change in total hip BMD (relative to baseline) at 36 months
    Percentage Change From Baseline in Femoral Neck BMD at 36 Months
    Percentage change in femoral neck BMD (relative to baseline) at 36 Months
    Percentage Change From Baseline in Trochanter BMD at 36 Months
    Percentage change in trochanter BMD (relative to baseline) at 36 months
    Percentage Change From Baseline in Total Body BMD at 36 Months
    Percentage change from baseline in total body BMD (relative to baseline) at 36 Months
    Percentage Change From Baseline in Distal Forearm BMD at 36 Months
    Percentage change in distal forearm BMD (relative to baseline) at 36 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 36 Months
    Percentage change from baseline in biochemical marker of bone turnover (u-NTx) at 36 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 36 Months
    Percentage change from baseline in biochemical marker of bone turnover (s-CTx) at 36 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months
    Percentage change from baseline in biochemical marker of bone turnover u-DPyr at 36 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months
    Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase [s-BSAP]) at 36 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months
    Percentage change from baseline in biochemical marker of bone turnover (serum N-terminal propeptide of Type 1 collagen [s-P1NP]) at 36 months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b [TRAP 5-b]) at 36 Months
    Percentage change from baseline in biochemical marker of bone turnover (serum bone tartrate-resistant acid phosphatase isoform 5b [TRAP 5-b]) at 36 Months
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months
    Percentage change from baseline in biochemical marker of bone turnover (serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months

    Full Information

    First Posted
    June 2, 2005
    Last Updated
    December 21, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00112437
    Brief Title
    A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004)
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin K Inhibitor) in the Treatment of Postmenopausal Women With Osteoporosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 24, 2005 (Actual)
    Primary Completion Date
    December 26, 2007 (Actual)
    Study Completion Date
    January 20, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a 1-year base study with a 1-year extension to examine the effects of a new experimental medication (odanacatib [MK-0822]) on postmenopausal osteoporosis. This study will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different doses of odanacatib or to placebo. Measurements performed during the study include: bone mineral density scans, spine x-rays, laboratory blood and urine tests, height measurements and optional bone biopsies (at the end of 2 years).
    Detailed Description
    Study Extension: Participants who completed 12 months of the base study and 12 months of the first extension were invited to continue in three additional extensions: MK0-822-004-10, which extended the study to 36 months, MK-0822-004-20 (NCT00112437) which extended the study to 60 months, and MK-0822-004-30 (NCT00112437), which extended the study to 120 months. In the first extension, participants continued to receive the same treatment they received in the 12-month base study. In the second extension, participants were re-randomized to odanacatib 50 mg OW or placebo OW for 12 months. In the third extension, participants who were initially randomized to odanacatib 3 mg or placebo OW in the base study received odanacatib 50 mg weekly in Years 4 and 5; all other participants remained on the same treatment they were during Year 3. In the fourth extension, all participants received odanacatib weekly in Years 6-10. Study arms for extensions include only odanacatib 50 mg and placebo for the first two extensions and odanacatib 50 mg only for the third extension. Extension Studies: MK-0822-004-10 (NCT00112437) Extension: Participant has participated in and completed 24 months of treatment in the base study MK-0822-004-20 (NCT00112437) Extension: Participant participated in and completed 36 months of treatment in base and extension studies. MK-0822-004-30 (NCT00112437) Extension: Participant participated in and completed 60 months of treatment in the base and extension studies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    399 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Odanacatib 3 mg
    Arm Type
    Experimental
    Arm Title
    Odanacatib 10 mg
    Arm Type
    Experimental
    Arm Title
    Odanacatib 25 mg
    Arm Type
    Experimental
    Arm Title
    Odanacatib 50 mg
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Odanacatib
    Other Intervention Name(s)
    MK-0822
    Intervention Description
    Odanacatib 3 mg, once weekly for 24 months
    Intervention Type
    Drug
    Intervention Name(s)
    Odanacatib
    Other Intervention Name(s)
    MK-0822
    Intervention Description
    Odanacatib 10 mg, once weekly for 24 months
    Intervention Type
    Drug
    Intervention Name(s)
    Odanacatib
    Other Intervention Name(s)
    MK-0822
    Intervention Description
    Odanacatib 25 mg, once weekly for 24 months
    Intervention Type
    Drug
    Intervention Name(s)
    Odanacatib
    Other Intervention Name(s)
    MK-0822
    Intervention Description
    Odanacatib 50 mg, once weekly for 24 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin D3
    Intervention Description
    Vitamin D3, two 2800 IU weekly throughout the study
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Calcium Carbonate
    Intervention Description
    Participants who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo to Odanacatib 3 mg, 10 mg, 25 mg, or 50 once weekly for 24 months
    Primary Outcome Measure Information:
    Title
    Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
    Description
    Percentage change in lumbar spine BMD (relative to baseline) at 12 Months.
    Time Frame
    Baseline and 12 months
    Title
    Percentage Change From Baseline in Lumbar Spine BMD at 24 Months
    Description
    Percentage change in lumbar spine BMD (relative to baseline) at 24 Months.
    Time Frame
    Baseline and 24 months
    Title
    Percentage Change From Baseline in Lumbar Spine BMD at 36 Months
    Description
    Percentage change in lumbar spine BMD (relative to baseline) at 36 months
    Time Frame
    Baseline and 36 months
    Title
    Percentage Change From Baseline in Lumbar Spine BMD at 60 Months
    Description
    Percentage change from baseline in lumbar spine BMD at 60 months.
    Time Frame
    Baseline and Month 60
    Title
    Percentage Change From Baseline in Lumbar Spine BMD at 120 Months
    Description
    Percentage change from baseline in lumbar spine BMD at 120 Months.
    Time Frame
    Baseline and Month 120
    Title
    Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment Years 6-10 (60 Months)
    Description
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
    Time Frame
    Years 6-10 (up to 60 months, up to 14 days after the last dose of study drug)
    Title
    Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Years 6-10 (60 Months)
    Description
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
    Time Frame
    Years 6-10 (up to 60 months)
    Secondary Outcome Measure Information:
    Title
    Percentage Change From Baseline in Total Hip BMD at 12 Months
    Description
    Percentage change in total hip BMD (relative to baseline) at 12 months
    Time Frame
    Baseline and 12 months
    Title
    Percentage Change From Baseline in Femoral Neck BMD at 12 Months
    Description
    Percentage change in femoral neck BMD (relative to baseline) at 12 months
    Time Frame
    Baseline and 12 months
    Title
    Percentage Change From Baseline in Trochanter BMD at 12 Months
    Description
    Percentage change in trochanter BMD (relative to baseline) at 12 months
    Time Frame
    Baseline and 12 Months
    Title
    Percentage Change From Baseline in Total Body BMD at 12 Months
    Description
    Percentage change in total body BMD (relative to baseline) at 12 months
    Time Frame
    Baseline and 12 Months
    Title
    Percentage Change From Baseline in Distal Forearm BMD at 12 Months
    Description
    Percentage change in distal forearm BMD (relative to baseline) at 12 months
    Time Frame
    Baseline and 12 Months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 12 Months
    Description
    Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u-NTx)) at 12 Months
    Time Frame
    Baseline and 12 Months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 12 Months
    Description
    Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) at 12 Months.
    Time Frame
    Baseline and 12 Months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 12 Months
    Description
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 12 Months
    Time Frame
    Baseline and 12 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 12 Months
    Description
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)), at 12 Months
    Time Frame
    Baseline and 12 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 12 Months
    Description
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen (s-P1NP) (relative to baseline) at 12 Months
    Time Frame
    Baseline and 12 months
    Title
    Percentage Change From Baseline in Total Hip Bone Mineral Density at 24 Months
    Description
    Percentage change in total hip Bone Mineral Density (relative to baseline) at 24 Months
    Time Frame
    Baseline and 24 months
    Title
    Percentage Change From Baseline in Femoral Neck BMD at 24 Months
    Description
    Percentage change in femoral neck Bone Mineral Density (relative to baseline) at 24 Months
    Time Frame
    Baseline and 24 months
    Title
    Percentage Change From Baseline in Trochanter BMD at 24 Months
    Description
    Percentage change from baseline in trochanter BMD (relative to baseline) at 24 Months
    Time Frame
    Baseline and 24 months
    Title
    Percentage Change From Baseline in Total Body BMD at 24 Months
    Description
    Percentage change in total body BMD (relative to baseline) at 24 Months
    Time Frame
    Baseline and 24 months
    Title
    Percentage Change From Baseline in Distal Forearm BMD at 24 Months
    Description
    Percentage change in distal forearm BMD (relative to baseline) at 24 Months
    Time Frame
    Baseline and 24 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 24 Months
    Description
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (u-NTx) (relative to baseline) at 24 Months
    Time Frame
    Baseline and 24 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 24 Months
    Description
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) (relative to baseline) at 24 Months
    Time Frame
    Baseline and 24 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 24 Months
    Description
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 24 Months
    Time Frame
    Baseline and 24 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 24 Months
    Description
    Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)) (relative to baseline) at 24 Months
    Time Frame
    Baseline and 24 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 24 Months
    Description
    Back-transformation (geometric mean) of the least squares mean of the log-values percentage change from baseline in biochemical marker of bone turnover (s-P1NP) (relative to baseline) at 24 months
    Time Frame
    Baseline and 24 months
    Title
    Percentage Change From Baseline in Total Hip BMD at 36 Months
    Description
    Percentage change in total hip BMD (relative to baseline) at 36 months
    Time Frame
    Baseline and 36 months
    Title
    Percentage Change From Baseline in Femoral Neck BMD at 36 Months
    Description
    Percentage change in femoral neck BMD (relative to baseline) at 36 Months
    Time Frame
    Baseline and 36 months
    Title
    Percentage Change From Baseline in Trochanter BMD at 36 Months
    Description
    Percentage change in trochanter BMD (relative to baseline) at 36 months
    Time Frame
    Baseline and 36 months
    Title
    Percentage Change From Baseline in Total Body BMD at 36 Months
    Description
    Percentage change from baseline in total body BMD (relative to baseline) at 36 Months
    Time Frame
    Baseline and 36 months
    Title
    Percentage Change From Baseline in Distal Forearm BMD at 36 Months
    Description
    Percentage change in distal forearm BMD (relative to baseline) at 36 Months
    Time Frame
    Baseline and 36 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 36 Months
    Description
    Percentage change from baseline in biochemical marker of bone turnover (u-NTx) at 36 Months
    Time Frame
    Baseline and 36 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 36 Months
    Description
    Percentage change from baseline in biochemical marker of bone turnover (s-CTx) at 36 Months
    Time Frame
    Baseline and 36 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months
    Description
    Percentage change from baseline in biochemical marker of bone turnover u-DPyr at 36 Months
    Time Frame
    Baseline and 36 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months
    Description
    Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase [s-BSAP]) at 36 Months
    Time Frame
    Baseline and 36 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months
    Description
    Percentage change from baseline in biochemical marker of bone turnover (serum N-terminal propeptide of Type 1 collagen [s-P1NP]) at 36 months
    Time Frame
    Baseline and 36 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b [TRAP 5-b]) at 36 Months
    Description
    Percentage change from baseline in biochemical marker of bone turnover (serum bone tartrate-resistant acid phosphatase isoform 5b [TRAP 5-b]) at 36 Months
    Time Frame
    Baseline and 36 months
    Title
    Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months
    Description
    Percentage change from baseline in biochemical marker of bone turnover (serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months
    Time Frame
    Baseline and 36 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Postmenopausal for 5 or more years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy Bone mineral density T-score at the hip or spine of -2.0 or less Spinal anatomy suitable for dual-energy x-ray absorptiometry (DXA). At the lumbar spine, there is no evidence of vertebral fracture in at least 3 vertebrae in the L1 to L4 region on baseline spine films. (Significant scoliosis, bony trauma, degenerative joint disease, and sequelae of orthopedic procedures that result in anatomy that is unsuitable for accurate bone densitometry must be absent from the lumbar spine.) At least one hip must be evaluable by DXA (e.g., contain no hardware from orthopedic procedures) In a state of general health allowing for successful completion of the trial Agreement to not use any medications to treat osteoporosis during the study Exclusion Criteria: History of prior osteoporotic fracture (unless declined treatment with or was ineligible for osteoporosis therapy) Past treatment with osteoporosis medications, steroids, hormone replacement, as well as various other medications that affect bone may be exclusionary. (Different exclusion criteria apply to each bone active drug. For example, any prior use of intravenous (IV) bisphosphonates is not permitted. By contrast, prior use of hormone replacement for several years is permitted if it has not occurred within the past 6 months. Please ask the study doctor for details) Significant clinical or laboratory abnormalities at the screening visit for the study that, in the opinion of the investigator, could complicate interpretation of the study results or pose additional risk to the patient (for example, patients who are non-ambulatory should be excluded for this reason)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19874198
    Citation
    Bone HG, McClung MR, Roux C, Recker RR, Eisman JA, Verbruggen N, Hustad CM, DaSilva C, Santora AC, Ince BA. Odanacatib, a cathepsin-K inhibitor for osteoporosis: a two-year study in postmenopausal women with low bone density. J Bone Miner Res. 2010 May;25(5):937-47. doi: 10.1359/jbmr.091035.
    Results Reference
    result
    PubMed Identifier
    22777865
    Citation
    Langdahl B, Binkley N, Bone H, Gilchrist N, Resch H, Rodriguez Portales J, Denker A, Lombardi A, Le Bailly De Tilleghem C, Dasilva C, Rosenberg E, Leung A. Odanacatib in the treatment of postmenopausal women with low bone mineral density: five years of continued therapy in a phase 2 study. J Bone Miner Res. 2012 Nov;27(11):2251-8. doi: 10.1002/jbmr.1695.
    Results Reference
    result
    PubMed Identifier
    26879200
    Citation
    Rizzoli R, Benhamou CL, Halse J, Miller PD, Reid IR, Rodriguez Portales JA, DaSilva C, Kroon R, Verbruggen N, Leung AT, Gurner D. Continuous treatment with odanacatib for up to 8 years in postmenopausal women with low bone mineral density: a phase 2 study. Osteoporos Int. 2016 Jun;27(6):2099-107. doi: 10.1007/s00198-016-3503-0. Epub 2016 Feb 15.
    Results Reference
    result
    PubMed Identifier
    20740685
    Citation
    Eisman JA, Bone HG, Hosking DJ, McClung MR, Reid IR, Rizzoli R, Resch H, Verbruggen N, Hustad CM, DaSilva C, Petrovic R, Santora AC, Ince BA, Lombardi A. Odanacatib in the treatment of postmenopausal women with low bone mineral density: three-year continued therapy and resolution of effect. J Bone Miner Res. 2011 Feb;26(2):242-51. doi: 10.1002/jbmr.212.
    Results Reference
    derived

    Learn more about this trial

    A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004)

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