A Study to Examine the Effects of MK0822 on Postmenopausal Osteoporosis - Full Text View

Purpose

This is a 2 year study to examine the effects of a new experimental medication on postmenopausal osteoporosis. This study will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different doses of the test drug or to placebo. Measurements performed during the study include: bone mineral density scans, spine x-rays, laboratory blood and urine tests, height measurements and optional bone biopsy (at the end of 2 years).

Condition	Intervention	Phase
Osteoporosis	Drug: Odanacatib	Phase II

MedlinePlus related topics:

Osteoporosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of MK0822 in the Treatment of Postmenopausal Women With Osteoporosis

Further study details as provided by Merck:

Primary Outcome Measures:

Percentage change from baseline in lumbar spine BMD at 12 Months [ Time Frame: at 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage change in hip, total body BMD and biochemical markers of bone turnover at 12 Months [ Time Frame: at 12 Months ] [ Designated as safety issue: No ]

Enrollment:	375
Study Start Date:	July 2005
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal for 5 or more years,defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy.
Bone mineral density (BMD) T-score at the hip or spine of -2.0 or less.
The patient has anatomy suitable for dual-energy x-ray absorptiometry (DXA). At the lumbar spine, there is no evidence of vertebral fracture in at least 3 vertebrae in the L1 to L4 region on baseline spine films. (Significant scoliosis, bony trauma, degenerative joint disease, and sequelae of orthopedic procedures that result in anatomy that is unsuitable for accurate bone densitometry must be absent from the lumbar spine.)
At least one hip must be evaluable by DXA (e.g., contain no hardware from orthopedic procedures).
In a state of general health allowing for successful completion of the trial.
Agreement to not use any medications to treat osteoporosis during the study.

Exclusion Criteria:

History of prior osteoporotic fracture (unless declined treatment with or was ineligible for osteoporosis therapy).
Past treatment with osteoporosis medications, steroids, hormone replacement, as well as various other medications that affect bone may be exclusionary. (Different exclusion criteria apply to each bone active drug. For example, any prior use of intravenous (IV) bisphosphonates is not permitted. By contrast, prior use of hormone replacement for several years is permitted if it has not occurred within the past 6 months. Please ask the study doctor for details).
The patient has significant clinical or laboratory abnormalities at the screening visit for the study that, in the opinion of the investigator, could complicate interpretation of the study results or pose additional risk to the patient (for example, patients who are non-ambulatory should be excluded for this reason).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112437

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_023, MK0822-004
First Received:	June 2, 2005
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00112437
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Musculoskeletal Diseases

Osteoporosis, Postmenopausal

Osteoporosis

Bone Diseases, Metabolic

Bone Diseases

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00112437