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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00692913
First received: June 4, 2008
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)
Dietary Supplement: Calcium Supplement 500 mg
Other: Referred-Care Model
Phase 3

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 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

    Percentage of participants with serum levels of 25-hydroxyvitamin D below

    20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls.



Secondary Outcome 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 ] [ Designated as safety issue: No ]
    N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (NTx) is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.

  • Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
    Bone-Specific Alkaline Phosphatase (BSAP) is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.

  • Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

    Percentage of participants with serum levels of 25-hydroxyvitamin D below

    20 ng/mL after 52 weeks of treatment (6 month extension study) with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls.


  • Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DEXA) and measured in g/cm^2 was obtained at baseline (visit 1) and Week 52 (visit 13) or at early study discontinuation visit. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent change from baseline, the greater the response to therapy.

  • Falls Per Participant [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]

    Number of falls per participant was measured.

    The fall event rate during the study period was defined as the number of adjudicated falls during the study period divided by the total patient-years in the study. Each participant was to be in the study for approximately one year.

    In order to guide and standardize all procedures during the fall adjudication process, a Standard Operating Procedure for Fall Adjudication was created by the

    SPONSOR and served as a guideline to standardize operational procedures for fall adjudication.


  • Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    NTx is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.

  • Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    BSAP is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.


Enrollment: 515
Study Start Date: June 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOSAVANCE 5600
alendronate sodium (+) cholecalciferol
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).

Referred-Care Model
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
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).

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692913

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00692913     History of Changes
Other Study ID Numbers: 0217A-262, 2007_653
Study First Received: June 4, 2008
Results First Received: July 20, 2011
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Alendronate
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014