A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262 AM1)(COMPLETED)

Official Title: “A Phase III (Phase V Program), Open-Label, Randomized, Referred-Care-Controlled, Clinical Trial to Evaluate the Efficacy and Safety of MK -0217A/Alendronate Sodium-70 mg/Vitamin D3 5600 I.U. Combination Tablet on Vitamin D Inadequacy in the Treatment of Osteoporosis in Postmenopausal Women”

A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.

Intervention(s) in this Clinical Trial

• Drug: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)
  • FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).
• Dietary Supplement: Calcium Supplement 500 mg
  • Calcium supplied locally by the investigator (containing 500 mg calcium supplement) daily for 52 weeks (unless the patient's dietary intake of calcium exceeds 1000 mg per day).
• Other: Referred-Care Model
  • Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: FOSAVANCE 5600
  • alendronate sodium (+) cholecalciferol
• Other: Referred-Care Model
  • Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.

Primary Measures

• Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26
  • Time Frame: Week 26
    Safety Issue?: No

Secondary Measures

• Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
  • Time Frame: Baseline and Week 26
    Safety Issue?: No
• Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase
  • Time Frame: Baseline and Week 26
    Safety Issue?: No
• Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52
  • Time Frame: Week 52
    Safety Issue?: No
• Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density
  • Time Frame: Baseline and Week 52
    Safety Issue?: No
• Falls Per Participant
  • Time Frame: Up to Week 52
    Safety Issue?: No
• Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
  • Time Frame: Baseline and Week 52
    Safety Issue?: No
• Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase
  • Time Frame: Baseline and Week 52
    Safety Issue?: No

Inclusion Criteria:

• Female
• 65 years or older
• Diagnosed with osteoporosis (Bone Mineral Density (BMD) T-score <= -2.5 at spine or hip) or prior fragility fracture BMD T-score <=-1.5 in at least one of the anatomic sites including lumbar spine, total hip, and femoral neck sites
• Postmenopausal
• Low levels of vitamin D as measured 25-hydroxyvitamin D
• Has fallen at least once within the past 12 months

Exclusion Criteria:

• Unable to stand or sit upright for at least 30 minutes
• Has a bone disorder other than osteoporosis
• Contraindication to the use of FOSAVANCE

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00692913

Study ID Number: MK-0217A-262

ClinicalTrials.gov Identifier: NCT00692913

Health Authority: United States: Food and Drug Administration