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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01552122

Enrollment

Registered

2012-03-13

Start date

2012-05-31

Completion date

2015-02-28

Last updated

2015-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal Osteoporosis

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.

Interventions

DRUGOdanacatib

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

DRUGAlendronate

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.

OTHERPlacebo (odanacatib)

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

DIETARY_SUPPLEMENTCholecalciferol (Vitamin D3)

Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.

DIETARY_SUPPLEMENTCalcium carbonate

Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.

OTHERPlacebo (alendronate)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

60 Years to No maximum

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™)

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026