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

NCT01803607 | Terminated Phase 3 Results DMC

• 1 other identifier: 0822-076
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline to Month 12 in Femoral BMD

  Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12.

  Baseline and Month 12

Secondary Outcomes (7)

• Percent Change From Baseline to Month 24 in Femoral Neck BMD: Within-Group Comparison of Odanacatib

  Baseline and Month 24

• Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD

  Baseline and Month 12

• Change From Baseline in Serum C-telopeptides of Type 1 Collagen (s-CTx)

  Baseline and Month 12

• Change From Baseline in Urine C-telopeptides of Type I Collagen (u-CTx)

  Baseline and Month 12

• Change From Baseline in Urine N-telopeptides of Type 1 Collagen Corrected for Creatinine (u-NTx/Cr)

  Baseline and Month 12

Study Arms (2)

Odanacatib 50 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

odanacatib DRUG

odanacatib 50 mg oral tablet

Also known as: MK-0822

Odanacatib 50 mg

placebo to odanacatib OTHER

dose-matched placebo to odanacatib, oral tablet

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Osteoporosis

Interventions

odanacatib

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 4, 2013
• Study Start: March 14, 2013
• Primary Completion: November 11, 2014
• Study Completion: November 11, 2014
• Last Updated: September 4, 2019
• Results First Posted: May 22, 2017

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share