Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)

A Phase III Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density, Tolerability, and Safety in the Treatment of Postmenopausal Women With Osteoporosis Previously Treated With Alendronate

This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.

Study Overview

• Status: Withdrawn
• Conditions: Osteoporosis; Postmenopausal Osteoporosis
• Intervention / Treatment: Drug: Odanacatib; Dietary supplement: Cholecalciferol (Vitamin D3); Dietary supplement: Calcium carbonate; Other: Placebo (alendronate); Drug: Alendronate; Other: Placebo (odanacatib)

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• In good general health, and postmenopausal for at least 5 years or more
• Diagnosed with postmenopausal osteoporosis
• Currently taking alendronate for at least 3 years or more for the treatment of osteoporosis
• One hip free of orthopedic hardware (ie, total hip device, hip pin); anatomy is suitable to undergo a dual-emission X-ray absorptiometry (DXA) scan (ie, bone mineral density scan)
• Agrees to not to use any other medications for the treatment of osteoporosis except those provided to the participant during the study

Exclusion Criteria:

• Evidence of metabolic bone disorder
• History of malignancy (cancer) for 5 years or less
• Active thyroid disease that cannot be managed with medication
• Severe renal insufficiency (kidney disease), myocardial infarction, unstable angina, stroke or revascularization, untreated malabsorption syndrome, and/or osteonecrosis of the jaw, or anticipates undergoing a major dental procedure (e.g. dental extraction or implantation)
• Use, misuse, abuse, and/or addiction of illicit drugs and/or recent history

(within the last year) of drug or alcohol abuse or dependence

• Use of estrogen with or without progestin and/or raloxifene (ie, Evista®) or tamoxifen (ie, Nolvadex®, Tamofen®)
• Use of any oral bisphosphonate therapy other than alendronate; intravenous bisphosphonates (zoledronate, ibandronate, pamidronate); any form of calcitonin other than intranasal; anabolic steroids; and/or Strontium-containing products (ie, Osteovalin™)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Odanacatib	Drug: Odanacatib; Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months; Other Names: MK-0822; Dietary supplement: Cholecalciferol (Vitamin D3); Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.; Dietary supplement: Calcium carbonate; Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.; Other: Placebo (alendronate); One compressed tablet administered orally, once-a-week, for 24 months.
ACTIVE_COMPARATOR: Alendronate	Dietary supplement: Cholecalciferol (Vitamin D3); Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.; Dietary supplement: Calcium carbonate; Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.; Drug: Alendronate; Alendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration.; Other Names: Fosamax; Alendronate Sodium; Other: Placebo (odanacatib); One compressed tablet administered orally, once-a-week, for 24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck	Baseline and Month 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter	Baseline and Month 24

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ANTICIPATED): February 1, 2015
• Study Completion (ANTICIPATED): February 1, 2015

Study Registration Dates

• First Submitted: March 9, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (ESTIMATE): March 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 27, 2015
• Last Update Submitted That Met QC Criteria: August 26, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antacids; Vitamin D; Cholecalciferol; Calcium; Alendronate; Calcium Carbonate
• Other Study ID Numbers: 0822-050