search
Back to results

A Study for the Transdermal Application of Teriparatide

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Subcutaneous Teriparatide
Transdermal Teriparatide
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Age Related Osteoporosis, Senile Osteoporosis

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Ambulatory, postmenopausal women.
  • Centrally confirmed lumbar spine or femoral neck bone mineral density (BMD) T-score of less than or equal to -2.5.
  • Without language barrier, cooperative, expected to return for all follow-up procedures, and have given informed consent after being informed of the risks, medications, and procedures to be used in the study.
  • Able to use the pen-type injection delivery system and the ViaDerm Teriparatide System satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver.
  • Able to be reached by telephone for follow-up contact between visits

Exclusion Criteria:

  • Abnormal laboratory values for albumin and alkaline phosphatase.
  • Laboratory values outside the ranges defined in the protocol for the following: Serum calcium, intact parathyroid hormone (iPTH), 25 hydroxyvitamin D, and 24-hour urine calcium
  • History of diseases other than postmenopausal osteoporosis that affect bone metabolism, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, and intestinal malabsorption.
  • History of malignant neoplasms in the 5 years prior to randomization, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized.
  • Use of a pacemaker.
  • Known chronic dermatological disorder, such as contact dermatitis
  • History of allergy or sensitivity to tapes or adhesives
  • Patients prone to bleeding with coagulopathies, such as hemophilia or thrombocytopenia.
  • Patients who have an increased baseline risk of osteosarcoma, Paget's disease of the bone, or unexplained elevations of alkaline phosphatase; or prior external beam, implant radiation therapy involving the skeleton, or previous primary skeletal malignancy.
  • Major fracture within the past year in the femur, tibia, humerus, or radius (with or without ulna).

Treatment with:

  • calcitonins in the 2 months prior to randomization.
  • oral, transdermal/patch, or injectable estrogens, progestins, estrogen analogs, estrogen agonists, estrogen antagonists, selective estrogen receptor modulators, or tibolone in the 3 months prior to randomization; treatment with intravaginal estrogens in doses higher than 0.3 mg of conjugated equine estrogen, or the equivalent, for more than 3 doses per week in the 3 months prior to randomization.
  • androgens or other anabolic steroids in the 6 months prior to randomization.
  • fluorides in the 2 years prior to randomization. (Previous or current use of fluoridated water or topical dental fluoride treatments are permitted.)
  • oral bisphosphonates for more than 2 consecutive months in the 6 months prior to randomization; treatment with intravenous bisphosphonates in the 6 months prior to randomization; treatment with more than 1 cycle of intermittent oral bisphosphonates in the 6 months prior to randomization; or having received the last cycle of this intermittent oral regimen less than 4 weeks prior to screening.
  • patients receiving intravenous zoledronic acid during the 12 months prior to randomization.
  • vitamin D greater than 50,000 International Units (IU) per week or with any dose of calcitriol or vitamin D analogs or agonists in the 6 months prior to randomization.
  • systemic corticosteroids in the 1 month prior to randomization or for more than 30 days in the 1 year prior to randomization. (Ophthalmic, otic, topical, orally inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used without these restrictions.)
  • any other drug known to significantly affect bone metabolism in the 6 months prior to randomization.
  • warfarin or other coumadin anticoagulants in the 1 month prior to randomization.
  • any investigational drug in the 1 month prior to entry into the study.

Sites / Locations

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

20 mcg Subcutaneous Teriparatide

30 mcg Transdermal Teriparatide

50 mcg Transdermal Teriparatide

80 mcg Transdermal Teriparatide

Arm Description

Received 20 micrograms (mcg) subcutaneously once daily in an unblinded manner.

Received 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.

Received 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.

Received 80 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.

Secondary Outcome Measures

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.
Time Course Change of BMD Response at the Lumbar Spine
To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).
Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Percent Change From Baseline of C-Terminal Telopeptide (CTX)
C-terminal telopeptide is a marker of bone resorption.
Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Convenience/Ease of Use Questionnaire (CEUQ)
CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + [(40 - albumin) x 0.02]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).
Change From Baseline in Urine Calcium Excretion at 6 and 12 Months
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).
Pharmacokinetics Parameters: Area Under the Curve (AUC)
Due to high intra-subject variability, data was not analyzed for this outcome measure.
Pharmacokinetics Parameters: Maximal Concentration (Cmax)
Due to high intra-subject variability, data was not analyzed for this outcome measure.
DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up
Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)
DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up
Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)

Full Information

First Posted
November 9, 2009
Last Updated
September 21, 2012
Sponsor
Eli Lilly and Company
Collaborators
TransPharma Medical
search

1. Study Identification

Unique Protocol Identification Number
NCT01011556
Brief Title
A Study for the Transdermal Application of Teriparatide
Official Title
A Phase 2 Study for Transdermal Application of Teriparatide
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
TransPharma Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of this study is to help answer the following research questions: How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or porous your bones are). The safety of the teriparatide skin patch and any side effects that might be associated with it.
Detailed Description
Teriparatide 20 micrograms (mcg) per day is currently only available as a subcutaneous (SQ) injection and many patients with severe osteoporosis for whom anabolic therapy with teriparatide is appropriate are either unwilling or physically unable to self-inject. The purpose of this Phase 2 study is to identify a transdermal dose or doses that will be comparable to the teriparatide 20 mcg SQ dose from a pharmacodynamic (PD) and safety standpoint for use in future Phase 3 studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Age Related Osteoporosis, Senile Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20 mcg Subcutaneous Teriparatide
Arm Type
Active Comparator
Arm Description
Received 20 micrograms (mcg) subcutaneously once daily in an unblinded manner.
Arm Title
30 mcg Transdermal Teriparatide
Arm Type
Experimental
Arm Description
Received 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
Arm Title
50 mcg Transdermal Teriparatide
Arm Type
Experimental
Arm Description
Received 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
Arm Title
80 mcg Transdermal Teriparatide
Arm Type
Experimental
Arm Description
Received 80 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
Intervention Type
Drug
Intervention Name(s)
Subcutaneous Teriparatide
Other Intervention Name(s)
recombinant human parathyroid hormone (rhPTH) (1-34), recombinant human teriparatide, Forteo, Forsteo, LY333334
Intervention Description
Administered subcutaneously once daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Transdermal Teriparatide
Other Intervention Name(s)
synthetic human parathyroid hormone (shPTH) (1-34), synthetic human teriparatide
Intervention Description
Administered transdermally, applied once daily for 6 hours over 12 months
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
Description
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.
Time Frame
Baseline, 12 Months
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months
Description
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.
Time Frame
Baseline, 6 Months
Title
Time Course Change of BMD Response at the Lumbar Spine
Description
To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).
Time Frame
Baseline to 6 Months and 12 Months
Title
Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)
Description
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Time Frame
Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Title
Percent Change From Baseline of C-Terminal Telopeptide (CTX)
Description
C-terminal telopeptide is a marker of bone resorption.
Time Frame
Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Title
Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month
Description
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Time Frame
Baseline, 1 Month
Title
Convenience/Ease of Use Questionnaire (CEUQ)
Description
CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.
Time Frame
baseline up to 12 months
Title
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
Description
Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + [(40 - albumin) x 0.02]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).
Time Frame
Baseline, 12 Months
Title
Change From Baseline in Urine Calcium Excretion at 6 and 12 Months
Time Frame
Baseline, 6 Months, 12 Months
Title
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
Description
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.
Time Frame
Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months
Title
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
Time Frame
Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months
Title
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
Description
Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).
Time Frame
Baseline and 1, 3, 12, and 13 Months (mon)
Title
Pharmacokinetics Parameters: Area Under the Curve (AUC)
Description
Due to high intra-subject variability, data was not analyzed for this outcome measure.
Time Frame
Baseline, 1 Month, 3 Months, and 12 Months
Title
Pharmacokinetics Parameters: Maximal Concentration (Cmax)
Description
Due to high intra-subject variability, data was not analyzed for this outcome measure.
Time Frame
Baseline, 1 Month, 3 Months, 12 Months
Title
DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up
Description
Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)
Time Frame
13 Month follow-up
Title
DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up
Description
Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)
Time Frame
13 Month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ambulatory, postmenopausal women. Centrally confirmed lumbar spine or femoral neck bone mineral density (BMD) T-score of less than or equal to -2.5. Without language barrier, cooperative, expected to return for all follow-up procedures, and have given informed consent after being informed of the risks, medications, and procedures to be used in the study. Able to use the pen-type injection delivery system and the ViaDerm Teriparatide System satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver. Able to be reached by telephone for follow-up contact between visits Exclusion Criteria: Abnormal laboratory values for albumin and alkaline phosphatase. Laboratory values outside the ranges defined in the protocol for the following: Serum calcium, intact parathyroid hormone (iPTH), 25 hydroxyvitamin D, and 24-hour urine calcium History of diseases other than postmenopausal osteoporosis that affect bone metabolism, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, and intestinal malabsorption. History of malignant neoplasms in the 5 years prior to randomization, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized. Use of a pacemaker. Known chronic dermatological disorder, such as contact dermatitis History of allergy or sensitivity to tapes or adhesives Patients prone to bleeding with coagulopathies, such as hemophilia or thrombocytopenia. Patients who have an increased baseline risk of osteosarcoma, Paget's disease of the bone, or unexplained elevations of alkaline phosphatase; or prior external beam, implant radiation therapy involving the skeleton, or previous primary skeletal malignancy. Major fracture within the past year in the femur, tibia, humerus, or radius (with or without ulna). Treatment with: calcitonins in the 2 months prior to randomization. oral, transdermal/patch, or injectable estrogens, progestins, estrogen analogs, estrogen agonists, estrogen antagonists, selective estrogen receptor modulators, or tibolone in the 3 months prior to randomization; treatment with intravaginal estrogens in doses higher than 0.3 mg of conjugated equine estrogen, or the equivalent, for more than 3 doses per week in the 3 months prior to randomization. androgens or other anabolic steroids in the 6 months prior to randomization. fluorides in the 2 years prior to randomization. (Previous or current use of fluoridated water or topical dental fluoride treatments are permitted.) oral bisphosphonates for more than 2 consecutive months in the 6 months prior to randomization; treatment with intravenous bisphosphonates in the 6 months prior to randomization; treatment with more than 1 cycle of intermittent oral bisphosphonates in the 6 months prior to randomization; or having received the last cycle of this intermittent oral regimen less than 4 weeks prior to screening. patients receiving intravenous zoledronic acid during the 12 months prior to randomization. vitamin D greater than 50,000 International Units (IU) per week or with any dose of calcitriol or vitamin D analogs or agonists in the 6 months prior to randomization. systemic corticosteroids in the 1 month prior to randomization or for more than 30 days in the 1 year prior to randomization. (Ophthalmic, otic, topical, orally inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used without these restrictions.) any other drug known to significantly affect bone metabolism in the 6 months prior to randomization. warfarin or other coumadin anticoagulants in the 1 month prior to randomization. any investigational drug in the 1 month prior to entry into the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Buenos Aires
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Parnu
ZIP/Postal Code
80010
Country
Estonia
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Tallin
ZIP/Postal Code
10138
Country
Estonia
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Tartu
ZIP/Postal Code
50410
Country
Estonia
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Szombathely
ZIP/Postal Code
H-9700
Country
Hungary
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Guadalajara
ZIP/Postal Code
44158
Country
Mexico
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Mexico City
ZIP/Postal Code
03300
Country
Mexico
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Bucharest
ZIP/Postal Code
011025
Country
Romania
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Lasi
ZIP/Postal Code
700111
Country
Romania
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Timisoara
ZIP/Postal Code
300736
Country
Romania

12. IPD Sharing Statement

Learn more about this trial

A Study for the Transdermal Application of Teriparatide

We'll reach out to this number within 24 hrs