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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01552122
• Other study ID #: 0822-050
• Status: Withdrawn
• Phase: Phase 3
• First received: March 9, 2012
• Last updated: August 26, 2015
• Start date: May 2012
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Odanacatib
Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months
• 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:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck		Baseline and Month 24	No
Secondary	Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter		Baseline and Month 24	No