A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)

NCT00885170 | Completed Phase 2 Results DMC

• 4 other identifiers: 0822-0422009_578CTRI/2009/091/0002182008-008257-30
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (3)

• Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24

  BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.

  Baseline and Month 24

• Percentage of Participants Experiencing One or More Adverse Events (AEs)

  An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

  Up to 25 months

• Percentage of Participants Discontinuing Study Drug Due to an AE

  An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

  Up to 24 months

Secondary Outcomes (22)

• Percent Change From Baseline in Femoral Neck BMD at Month 12

  Baseline and 12 Months

• Percent Change From Baseline in Trochanter BMD at Month 24

  Baseline and 24 Months

• Percent Change From Baseline in Trochanter BMD at Month 12

  Baseline and 12 Months

• Percent Change From Baseline in Total Hip BMD at Month 24

  Baseline and 24 Months

• Percent Change From Baseline in Total Hip BMD at Month 12

  Baseline and 12 Months

Study Arms (2)

Odanacatib 50 mg

EXPERIMENTAL

Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Drug: Odanacatib; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium

Placebo

PLACEBO COMPARATOR

Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Drug: Placebo; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium

Interventions

Odanacatib DRUG

Odanacatib 50 mg tablets once weekly for 24 months

Odanacatib 50 mg

Placebo DRUG

Placebo to odanacatib 50 mg tablets once weekly for 24 months

Placebo

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months

Odanacatib 50 mg; Placebo

Calcium DIETARY_SUPPLEMENT

Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Odanacatib 50 mg; Placebo

Eligibility Criteria

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

You may qualify if:

• Has been postmenopausal for at least 5 years
• Has taken or is taking alendronate
• Agrees not to use medications for osteoporosis other than what is provided by the study

You may not qualify if:

• Has a history or evidence of hip fracture
• Has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
• Has active parathyroid disease
• Has a history of thyroid disease not adequately controlled by medication
• Is taking anti-seizure medication and has abnormal calcium metabolism
• Has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Bonnick S, De Villiers T, Odio A, Palacios S, Chapurlat R, DaSilva C, Scott BB, Le Bailly De Tilleghem C, Leung AT, Gurner D. Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Dec;98(12):4727-35. doi: 10.1210/jc.2013-2020. Epub 2013 Sep 24.

  PMID: 24064689 RESULT

MeSH Terms

Conditions

Osteoporosis

Interventions

odanacatib; Cholecalciferol; Calcium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

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 Monitor

  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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 21, 2009
• Study Start: April 13, 2009
• Primary Completion: September 15, 2011
• Study Completion: September 15, 2011
• Last Updated: August 28, 2018
• Results First Posted: April 18, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share