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Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)

Primary Purpose

Osteoporosis, Postmenopausal Osteoporosis

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Odanacatib

Alendronate

Placebo (odanacatib)

Cholecalciferol (Vitamin D3)

Calcium carbonate

Placebo (alendronate)

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

In good general health, and postmenopausal for at least 5 years or more
Diagnosed with postmenopausal osteoporosis
Currently taking alendronate for at least 3 years or more for the treatment of osteoporosis
One hip free of orthopedic hardware (ie, total hip device, hip pin); anatomy is suitable to undergo a dual-emission X-ray absorptiometry (DXA) scan (ie, bone mineral density scan)
Agrees to not to use any other medications for the treatment of osteoporosis except those provided to the participant during the study

Exclusion Criteria:

Evidence of metabolic bone disorder
History of malignancy (cancer) for 5 years or less
Active thyroid disease that cannot be managed with medication
Severe renal insufficiency (kidney disease), myocardial infarction, unstable angina, stroke or revascularization, untreated malabsorption syndrome, and/or osteonecrosis of the jaw, or anticipates undergoing a major dental procedure (e.g. dental extraction or implantation)
Use, misuse, abuse, and/or addiction of illicit drugs and/or recent history

(within the last year) of drug or alcohol abuse or dependence

Use of estrogen with or without progestin and/or raloxifene (ie, Evista®) or tamoxifen (ie, Nolvadex®, Tamofen®)
Use of any oral bisphosphonate therapy other than alendronate; intravenous bisphosphonates (zoledronate, ibandronate, pamidronate); any form of calcitonin other than intranasal; anabolic steroids; and/or Strontium-containing products (ie, Osteovalin™)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Odanacatib

Alendronate

Arm Description

Outcomes

Primary Outcome Measures

Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck

Secondary Outcome Measures

Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter

Full Information

NCT ID

NCT01552122

First Posted

March 9, 2012

Last Updated

August 26, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01552122

Brief Title

Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)

Official Title

A Phase III Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density, Tolerability, and Safety in the Treatment of Postmenopausal Women With Osteoporosis Previously Treated With Alendronate

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Withdrawn

Study Start Date

May 2012 (undefined)

Primary Completion Date

February 2015 (Anticipated)

Study Completion Date

February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.

6. Conditions and Keywords

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

Osteoporosis, Postmenopausal Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Odanacatib

Arm Type

Experimental

Arm Title

Alendronate

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Odanacatib

Other Intervention Name(s)

MK-0822

Intervention Description

Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months

Intervention Type

Drug

Intervention Name(s)

Alendronate

Other Intervention Name(s)

Alendronate Sodium, Fosamax

Intervention Description

Alendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration.

Intervention Type

Other

Intervention Name(s)

Placebo (odanacatib)

Intervention Description

One compressed tablet administered orally, once-a-week, for 24 months.

Intervention Type

Dietary Supplement

Intervention Name(s)

Cholecalciferol (Vitamin D3)

Intervention Description

Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium carbonate

Intervention Description

Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.

Intervention Type

Other

Intervention Name(s)

Placebo (alendronate)

Intervention Description

One compressed tablet administered orally, once-a-week, for 24 months.

Primary Outcome Measure Information:

Title

Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck

Time Frame

Baseline and Month 24

Secondary Outcome Measure Information:

Title

Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter

Time Frame

Baseline and Month 24

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: In good general health, and postmenopausal for at least 5 years or more Diagnosed with postmenopausal osteoporosis Currently taking alendronate for at least 3 years or more for the treatment of osteoporosis One hip free of orthopedic hardware (ie, total hip device, hip pin); anatomy is suitable to undergo a dual-emission X-ray absorptiometry (DXA) scan (ie, bone mineral density scan) Agrees to not to use any other medications for the treatment of osteoporosis except those provided to the participant during the study Exclusion Criteria: Evidence of metabolic bone disorder History of malignancy (cancer) for 5 years or less Active thyroid disease that cannot be managed with medication Severe renal insufficiency (kidney disease), myocardial infarction, unstable angina, stroke or revascularization, untreated malabsorption syndrome, and/or osteonecrosis of the jaw, or anticipates undergoing a major dental procedure (e.g. dental extraction or implantation) Use, misuse, abuse, and/or addiction of illicit drugs and/or recent history (within the last year) of drug or alcohol abuse or dependence Use of estrogen with or without progestin and/or raloxifene (ie, Evista®) or tamoxifen (ie, Nolvadex®, Tamofen®) Use of any oral bisphosphonate therapy other than alendronate; intravenous bisphosphonates (zoledronate, ibandronate, pamidronate); any form of calcitonin other than intranasal; anabolic steroids; and/or Strontium-containing products (ie, Osteovalin™)

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)

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