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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01803607
First received: February 28, 2013
Last updated: August 28, 2014
Last verified: August 2014
  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.


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 Blind (Subject, 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 24 in femoral neck bone mineral density (BMD): odanacatib versus placebo [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Percent change from baseline to month 24 in trochanter, total hip, and lumbar spine BMD [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline to month 24 in urine N-telopeptides of Type 1 collagen corrected for creatinine (u-NTx/Cr) after log-transformation [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
  • Change from baseline to month 24 in serum bone specific alkaline phosphatase (s-BSAP) after log-transformation [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: March 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (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

Ages Eligible for Study:   60 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803607

Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 74 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01803607     History of Changes
Other Study ID Numbers: 0822-076
Study First Received: February 28, 2013
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014