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

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01552122

Collaborator

(none)

Enrollment

Arms

33.1

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Postmenopausal Osteoporosis	Drug: Odanacatib Drug: Alendronate Other: Placebo (odanacatib) Dietary Supplement: Cholecalciferol (Vitamin D3) Dietary Supplement: Calcium carbonate Other: Placebo (alendronate)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2012

Anticipated Primary Completion Date :

Feb 1, 2015

Anticipated Study Completion Date :

Feb 1, 2015

Arms and Interventions

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	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: Alendronate Sodium Fosamax Other: Placebo (odanacatib) One compressed tablet administered orally, once-a-week, for 24 months. 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.

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

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:

Alendronate Sodium

Fosamax

Other: Placebo (odanacatib)

One compressed tablet administered orally, once-a-week, for 24 months.

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.

Outcome Measures

Primary Outcome Measures

Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck [Baseline and Month 24]

Secondary Outcome Measures

Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter [Baseline and Month 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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™)