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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01552122

First received: March 9, 2012

Last updated: June 7, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 9, 2012
Last Updated Date	June 7, 2012
Start Date ^ICMJE	May 2012
Estimated Primary Completion Date	February 2015 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 9, 2012)	Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01552122 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 9, 2012)	Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Osteoporosis Postmenopausal Osteoporosis
Intervention ^ICMJE	Drug: Odanacatib Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months Other Name: MK-0822 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. Other: Placebo (alendronate) One compressed tablet administered orally, once-a-week, for 24 months.
Study Arm (s)	Experimental: Odanacatib Interventions: Drug: Odanacatib Dietary Supplement: Cholecalciferol (Vitamin D3) Dietary Supplement: Calcium carbonate Other: Placebo (alendronate) Active Comparator: Alendronate Interventions: Drug: Alendronate Other: Placebo (odanacatib) Dietary Supplement: Cholecalciferol (Vitamin D3) Dietary Supplement: Calcium carbonate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	0
Estimated Completion Date	February 2015
Estimated Primary Completion Date	February 2015 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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™)
Gender	Female
Ages	60 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01552122
Other Study ID Numbers ^ICMJE	0822-050
Has Data Monitoring Committee	Yes
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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