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Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01803607
Recruitment Status : Terminated (Study halted prematurely due to low enrollment.)
First Posted : March 4, 2013
Results First Posted : May 22, 2017
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE February 28, 2013
First Posted Date  ICMJE March 4, 2013
Results First Submitted Date  ICMJE February 27, 2017
Results First Posted Date  ICMJE May 22, 2017
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE March 14, 2013
Actual Primary Completion Date November 11, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
Percent Change From Baseline to Month 12 in Femoral BMD [ Time Frame: Baseline and Month 12 ]
Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12.
Original Primary Outcome Measures  ICMJE
 (submitted: February 28, 2013)
Percent change from baseline to month 24 in femoral neck bone mineral density (BMD): odanacatib versus placebo [ Time Frame: Baseline and Month 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
  • Percent Change From Baseline to Month 24 in Femoral Neck BMD: Within-Group Comparison of Odanacatib [ Time Frame: Baseline and Month 24 ]
    DXA was used to determine the within-group change from baseline in femoral neck BMD at Month 24.
  • Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD [ Time Frame: Baseline and Month 12 ]
    DXA was used to determine the change from baseline in trochanter, total hip, and lumbar spine BMD at Month 12.
  • Change From Baseline in Serum C-telopeptides of Type 1 Collagen (s-CTx) [ Time Frame: Baseline and Month 12 ]
    s-CTx is a biochemical marker of bone resorption. At baseline and Month 12, s-CTx was measured and expressed in ng/mL and results are expressed as percentage change from baseline.
  • Change From Baseline in Urine C-telopeptides of Type I Collagen (u-CTx) [ Time Frame: Baseline and Month 12 ]
    u-CTx is a biochemical marker of bone resorption. At baseline and Month 12, u-CTx was measured and expressed in ug/mL and results are expressed as percentage change from baseline.
  • Change From Baseline in Urine N-telopeptides of Type 1 Collagen Corrected for Creatinine (u-NTx/Cr) [ Time Frame: Baseline and Month 12 ]
    The u-NTx/Cr ratio is a biochemical marker of bone resorption. u-NTx/Cr was measured at baseline and Month 12 and expressed in nM:mM and results are expressed as percentage change from baseline.
  • Change From Baseline in Serum Bone Specific Alkaline Phosphatase (s-BSAP) [ Time Frame: Baseline and Month 12 ]
    s-BSAP is a biochemical marker of bone resorption. s-BSAP was measured and expressed in ng/mL at Baseline and Month 12, and results are shown as percentage change from baseline.
  • Change From Baseline in Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP) [ Time Frame: Baseline and Month 12 ]
    s-P1NP is a biochemical marker of bone resorption. s-P1NP was measured and expressed as ng/mL at Baseline and Month 12, and results are expressed as percentage change from baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2013)
  • Percent Change From Baseline to Month 24 in Femoral Neck BMD: Within-Group Comparison of Odanacatib [ Time Frame: Baseline and Month 24 ]
  • Percent change from baseline to month 24 in trochanter, total hip, and lumbar spine BMD [ Time Frame: Baseline and Month 24 ]
  • Change from baseline to month 24 in serum C-telopeptides of Type 1 collagen (s-CTx) after log-transformation [ Time Frame: Baseline and Month 24 ]
  • Change from baseline to month 24 in urine C-telopeptides of Type I collagen (u-CTx) after log-transformation [ Time Frame: Baseline and Month 24 ]
  • Change from baseline to month 24 in urine N-telopeptides of Type 1 collagen (u-NTx) after log-transformation [ Time Frame: Baseline and Month 24 ]
  • Change from baseline to month 24 in serum bone specific alkaline phosphatase (s-BSAP) after log-transformation [ Time Frame: Baseline and Month 24 ]
  • Change from baseline to month 24 in serum N-terminal propeptide of Type 1 collagen (s-P1NP) after log-transformation [ Time Frame: Baseline and Month 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076)
Official Title  ICMJE A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate
Brief Summary The purpose of this study is to assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (BMD) over time in female participants who have received at least 3 years of bisphosphonate therapy. It was hypothesized that odanacatib treatment would increase femoral neck BMD relative to placebo after 24 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Drug: odanacatib
    odanacatib 50 mg oral tablet
    Other Name: MK-0822
  • Other: placebo to odanacatib
    dose-matched placebo to odanacatib, oral tablet
Study Arms  ICMJE
  • Experimental: Odanacatib 50 mg
    Participants will receive odanacatib 50 mg once weekly for 24 months. Additionally, all participants will receive weekly supplementation with 5600 international units (IU) of Vitamin D3 and, if required, will be provided with an open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
    Intervention: Drug: odanacatib
  • Placebo Comparator: Placebo
    Participants will receive dose-matched placebo to odanacatib once weekly for 24 months. Additionally, all participants will receive weekly supplementation with 5600 IU Vitamin D3 and, if required, will be provided with an open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
    Intervention: Other: placebo to odanacatib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 30, 2014)
135
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2013)
420
Actual Study Completion Date  ICMJE November 11, 2014
Actual Primary Completion Date November 11, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal for ≥5 years (defined as no menses for at least 5 years or at least 5 years post bilateral oophorectomy).
  • Prior or current treatment with oral bisphosphonate therapy (i.e., alendronate, risedronate, ibandronate) for postmenopausal osteoporosis for ≥3 years.
  • BMD T-score at any hip site (femoral neck, trochanter, or total hip) ≤-2.5 and >-3.5 as assessed by dual-energy X-ray absorptiometry (DXA) without a history of a prior fragility fracture. For participants with a history of a prior fragility fracture (except hip fracture), BMD T-score can be ≤-1.5 and >-3.5 at any hip site.
  • Serum 25-hydroxyvitamin D level of ≥20 and ≤60 ng/mL within 90 days of the time of randomization.

Exclusion Criteria:

  • Evidence of a metabolic bone disorder other than osteopenia or osteoporosis
  • History or current evidence of hip fracture.
  • History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  • Active parathyroid disease. Participant with a documented history of parathyroid disease can be considered for inclusion if she has normal parathyroid hormone (PTH) at screening.
  • History of thyroid disease not adequately controlled by medication.
  • Current treatment with anti-seizure medication, with indices of calcium metabolism not within normal limits.
  • Prior treatment with strontium-containing products; intravenous bisphosphonates; cathepsin K inhibitors; RANK ligand inhibitors; fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks.
  • Use of following medications within the 6 months prior to the screening visit: activated vitamin D; estrogen, with or without progestin, at a dose high enough to have systemic effects; raloxifene or other selective estrogen receptor modulator (SERM), tibolone or any aromatase inhibitor; sub-cutaneous calcitonin (Note: use of intranasal calcitonin is allowed at any time); anabolic steroid; PTH (1-34 or 1-84); growth hormone; systemic glucocorticoids (≥5 mg/day of prednisone or equivalent) for more than 2 weeks; cyclosporine for more than 2 weeks.
  • Concurrent use of cancer chemotherapy or heparin; protease inhibitors for human immunodeficiency virus (HIV) treatment; and vitamin A (excluding beta carotene) >10,000 IU daily, unless willing to discontinue this dose during the study.
  • Current treatment with cytochrome P450 3A4 (CYP3A4) inducers or treatment with CYP3A4 inducer within 4 weeks of screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01803607
Other Study ID Numbers  ICMJE 0822-076
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP