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

This study has been terminated.
(Study halted prematurely due to low enrollment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01803607
First Posted: March 4, 2013
Last Update Posted: May 22, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Osteoporosis Drug: odanacatib Other: placebo to odanacatib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 135
Study Start Date: March 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: odanacatib
odanacatib 50 mg oral tablet
Other Name: MK-0822
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.
Other: placebo to odanacatib
dose-matched placebo to odanacatib, oral tablet

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803607


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01803607     History of Changes
Other Study ID Numbers: 0822-076
First Submitted: February 28, 2013
First Posted: March 4, 2013
Results First Submitted: February 27, 2017
Results First Posted: May 22, 2017
Last Update Posted: May 22, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Carbonate
Diphosphonates
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Bone Density Conservation Agents
Physiological Effects of Drugs