Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis - Full Text View

Purpose

To demonstrate the efficacy/safety of Fosamax Plus D

Condition	Intervention	Phase
Osteoporosis Postmenopausal	Drug: alendronate sodium (+) cholecalciferol Drug: Comparator: Alendronate sodium (Fosamax) Dietary Supplement: Comparator: Calcium	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women

Resource links provided by NLM:

MedlinePlus related topics: Calcium Osteoporosis

Drug Information available for: Cholecalciferol Calcium Gluconate Alendronate sodium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Enrollment:	343
Study Start Date:	March 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Alendronate sodium/Cholecalciferol	Drug: alendronate sodium (+) cholecalciferol Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks Other Name: Fosamax Plus D Dietary Supplement: Comparator: Calcium 500 mg oral tablet calcium once daily, for 16 weeks
Active Comparator: 2 Alendronate sodium	Drug: Comparator: Alendronate sodium (Fosamax) Alendronate sodium; tablet, once weekly, for 16 weeks Dietary Supplement: Comparator: Calcium 500 mg oral tablet calcium once daily, for 16 weeks

Eligibility

Criteria

Inclusion Criteria:

Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
Patient has been diagnosed with osteoporosis
Patient has been postmenopausal for more than 6 months
Patient has no contraindication to taking oral bisphosphonates
Patient is eligible for dual energy x-ray absorptiometry in spine or hip

Exclusion Criteria:

Patients with esophageal dysfunction
Patients who can not sit or stand at least 30 minutes
Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial
Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism
Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729651

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00729651 History of Changes
Other Study ID Numbers:	2008_015, MK0217A-263
Study First Received:	August 5, 2008
Results First Received:	February 5, 2010
Last Updated:	April 6, 2010
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Cholecalciferol
Alendronate

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

ClinicalTrials.gov processed this record on May 23, 2013