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Efficacy and Safety Study of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis
This study is currently recruiting participants.
Verified by Merck, January 2009
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00729651
  Purpose

To demonstrate the efficacy/safety of FOSAMAX PLUS D.


Condition Intervention Phase
Osteoporosis Postmenopausal
Drug: Alendronate sodium/Cholecalciferol (FOSAMAX Plus D)
Drug: Alendronate sodium (FOSAMAX)
Phase III

MedlinePlus related topics: Dietary Sodium Osteoporosis
Drug Information available for: Alendronate Alendronate sodium Cholecalciferol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase IV (Phase V Program), Prospective, Randomized, Open-Label, Active-Controlled, Clinical Trial to Study the Efficacy and Safety of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis

Further study details as provided by Merck:

Primary Outcome Measures:
  • Proportion of patients with serum 25OHD below the insufficiency level (less than 15ng/ml) [ Time Frame: 16wks ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: March 2008
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Alendronate sodium/Cholecalciferol
Drug: Alendronate sodium/Cholecalciferol (FOSAMAX Plus D)
Alendronate sodium/Cholecalciferol ; tablet, once weekly, 16wks
2: Active Comparator
Alendronate sodium
Drug: Alendronate sodium (FOSAMAX)
Alendronate sodium ; tablet, once weekly, 16wks

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a spine or hip anatomy suitable for dual-energy x-ray absorptiometry
  • Patient has been postmenopausal defined as

    • A) greater than and equal to 1 year beyond the lmp (last menstrual period) in women greater than and equal to 50 years of age with who did not received hysterectomy
    • B) serum fsh greater than and equal to 30 iu/l in women who underwent hysterectomy
    • C) post bilateral oophorectomy
  • Patient has serum 25(oh)d greater than and equal to 9 ng/ml.
  • Patient with mean serum 25(oh)d is greater than and equal to 9 ng/ml, but not higher than 15 ng/ml (in 2 assay) is required to have serum pth and total alkaline phosphatase within the reference range
  • Patient is suitable for treatment with oral bisphosphonate.
  • Patient meets one of the following:

    • A) patient is a candidate for osteoporosis therapy with bisphosphonates, has bmd t-score less than and equal to 2.5 at at least one of testing locations including total hip, spine and femoral neck,
    • B) patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or pth), has bmd t-score less than and equal to 2.0 and have 1 prior vertebral fracture (l1-l4),
    • C) patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or pth), have greater than and equal to 2 prior vertebral fracture (l1-l4), or note: eligibility for this criterion is based on spine or femoral (neck or total) bmd
  • Patient understands the study procedures, alternative treatments available and risks involved with the study, and voluntarily agrees to use sun cream and limit direct solar exposure in a hour/day for 16 weeks and participate by giving a written informed consent
  • Patient with pth higher than 72 ng/l at baseline will be excluded, however, a 10 % variance would be allowed

Exclusion criteria:

  • Patient has or has had a history of malignancy or active systemic diseases less than 5 years prior to signing informed consent
  • Patient with abnormalities of the esophagus that delay esophageal emptying
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729651

Locations
Korea, Republic of
MSD Korea Ltd. Recruiting
Seoul, Korea, Republic of, 121-705
Contact: Steve Kim     82-2-6363-0241        
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: 2008_015, MK217A-263
Study First Received: August 5, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00729651  
Health Authority: Korea: Food and Drug Administration

Study placed in the following topic categories:
Cholecalciferol
Musculoskeletal Diseases
Alendronate
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009