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

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 21, 2013
Last verified: August 2013

June 4, 2008
August 21, 2013
June 2008
July 2010   (final data collection date for primary outcome measure)
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.

Test safety and tolerability of study drug and compare results, of vitamin D levels in the blood, in women using study drug versus women receiving standard care treatment. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00692913 on ClinicalTrials.gov Archive Site
  • 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.
Measure biochemical markers that indicate osteoporosis in women using study drug versus women receiving standard care treatment. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262 AM1)(COMPLETED)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis
  • 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).
  • Experimental: FOSAVANCE 5600
    alendronate sodium (+) cholecalciferol
    Interventions:
    • Drug: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)
    • Dietary Supplement: Calcium Supplement 500 mg
  • Referred-Care Model
    Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
    Intervention: Other: Referred-Care Model
Ralston SH, Binkley N, Boonen S, Kiel DP, Reginster JY, Roux C, Chen L, Rosenberg E, Santora A; FOCUS-D (FOSAVANCE vs. Standard Care-Use and Study of Vitamin D) Trial. Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency. Calcif Tissue Int. 2011 Jun;88(6):485-94. doi: 10.1007/s00223-011-9482-4. Epub 2011 Apr 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
515
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Female
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00692913
0217A-262, 2007_653
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP