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Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

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ClinicalTrials.gov Identifier: NCT00729651
Recruitment Status : Completed
First Posted : August 7, 2008
Results First Posted : April 2, 2010
Last Update Posted : May 12, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
To demonstrate the efficacy/safety of Fosamax Plus D

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : March 20, 2008
Primary Completion Date : April 10, 2009
Study Completion Date : April 10, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment [ Time Frame: Baseline and 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729651

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00729651     History of Changes
Other Study ID Numbers: 0217A-263
First Posted: August 7, 2008    Key Record Dates
Results First Posted: April 2, 2010
Last Update Posted: May 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:



Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents