A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018 AM5, EXT1) - Full Text View

Purpose

The purpose of the event-driven base study is to determine the safety and efficacy effects, especially fracture-risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis. In a placebo-controlled extension of the base study, participants will continue to receive the same blinded study medication up to 5 years of blinded study medication combined between the base study and the extension.

Condition	Intervention	Phase
Postmenopausal Osteoporosis	Drug: Odanacatib Drug: Placebo for Odanacatib Dietary Supplement: Vitamin D3	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary multiple exostoses

MedlinePlus related topics: Calcium Fractures Osteoporosis Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

(Base Study + Extension) Time From Baseline to First Morphometrically-Assessed Vertebral Fracture [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Base Study) Time From Baseline to First Hip Fracture (Adjudicated as Osteoporotic) [ Time Frame: Baseline to date of fracture ] [ Designated as safety issue: No ]
(Base Study) Time From Baseline to First Clinical Non-Vertebral Fracture (Adjudicated as Osteoporotic) [ Time Frame: Baseline to date of fracture ] [ Designated as safety issue: No ]
(Imaging Substudy PN032) Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) at the Lumbar Spine Using Quantitative Computed Tomography [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

(Base Study and Extension) Time From Baseline to First Clinical Osteoporotic Vertebral Fracture (Adjudicated) [ Time Frame: Baseline to date of fracture (up to 5 years) ] [ Designated as safety issue: No ]
(Base Study and Extension) Change in Height From Baseline Stature [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Base Study and Extension) Percent Change from Baseline in BMD Measurements of the Lumbar Spine [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Base Study) Change From Baseline in Serum C-Telopeptides of Type I Collagen (s-CTx) After Log-Transformation [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Imaging Substudy PN032) Percent Change From Baseline in Cortical Volumetric BMD of the Hip Using Quantitative Computed Tomography [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
(Base Study) Percent Change from Baseline in BMD Measurements of the Total Hip [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Base Study and Extension) Percent Change from Baseline in BMD Measurements of the Femoral Neck [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Base Study and Extension) Percent Change from Baseline in BMD Measurements of the Trochanter [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Base Study) Percent Change from Baseline in BMD Measurements of the Distal-Third Forearm [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Base Study) Percent Change From Baseline in BMD Measurements of the Lumbar Spine in Bisphosphonate-Intolerant Participants [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Base Study) Percent Change From Baseline in BMD Measurements of the Total Hip in Bisphosphonate-Intolerant Participants [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Base Study) Percent Change From BMD Measurements of the Femoral Neck in Bisphosphonate-Intolerant Participants [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Base Study) Percent Change From Baseline in BMD Measurements of the Trochanter in Bisphosphonate-Intolerant Participants [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Base Study) Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm in Bisphosphonate-Intolerant Participants [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
(Base Study) Change From Baseline in Urinary N-Telopeptides of Type I Collagen (u-NTx) After Log-Transformation [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]

Enrollment:	16716
Study Start Date:	September 2007
Estimated Study Completion Date:	November 2014
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Odanacatib Participants receive 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total), followed by 50 mg of open-label odanacatib weekly for 5 years. All participants will also receive Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is at least 1200 mg.	Drug: Odanacatib 50 mg tablet orally once weekly Other Name: MK-0822 Dietary Supplement: Vitamin D3 5600 IU orally once weekly
Placebo Comparator: Placebo Participants receive 50 mg of blinded placebo to odanacatib weekly over the course of the base study and first extension study (5 years total), followed by 50 mg of open-label odanacatib weekly for 5 years. All participants will also receive Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is at least 1200 mg.	Drug: Placebo for Odanacatib 50 mg tablet orally once weekly Dietary Supplement: Vitamin D3 5600 IU orally once weekly

Arms

Assigned Interventions

Experimental: Odanacatib

Participants receive 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total), followed by 50 mg of open-label odanacatib weekly for 5 years. All participants will also receive Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is at least 1200 mg.

Drug: Odanacatib

50 mg tablet orally once weekly

Other Name: MK-0822

Dietary Supplement: Vitamin D3

5600 IU orally once weekly

Placebo Comparator: Placebo

Participants receive 50 mg of blinded placebo to odanacatib weekly over the course of the base study and first extension study (5 years total), followed by 50 mg of open-label odanacatib weekly for 5 years. All participants will also receive Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is at least 1200 mg.

Drug: Placebo for Odanacatib

50 mg tablet orally once weekly

Dietary Supplement: Vitamin D3

5600 IU orally once weekly

Detailed Description:

There are two substudies related to base study MK-0822-018:

MK-0822-032 (Imaging substudy) Full title: An Imaging Sub-Study of the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium.

MK-0822-035 (Sarcopenia substudy) Full title: A Sub-Study to Explore Biomarker of Physical Function in the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women (for at least 5 years) who are ≥65 years of age and have low bone mineral density
Ambulatory (able to walk)

Exclusion Criteria:

Must not be taking osteoporosis therapy or have a metabolic bone disorder other than osteoporosis
Has or has had a hip fracture
Currently participating in another drug study

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00529373 History of Changes
Other Study ID Numbers:	0822-018, 2007_610
Study First Received:	September 12, 2007
Last Updated:	April 18, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Cholecalciferol
Vitamin D

Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013