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Completed

NCT Number: NCT00692913

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)

Drug

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).

Calcium Supplement 500 mg

Dietary Supplement

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

Other

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).

Primary outcomes

  1. Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26

    Time frame: Week 26

    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 outcomes

  1. Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio

    Time frame: Baseline and Week 26

    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.

  2. Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase

    Time frame: Baseline and Week 26

    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.

  3. Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52

    Time frame: Week 52

    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.

  4. Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density

    Time frame: Baseline and Week 52

    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.

  5. Falls Per Participant

    Time frame: Up to Week 52

    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.

  6. Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio

    Time frame: Baseline and Week 52

    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.

  7. Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase

    Time frame: Baseline and Week 52

    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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 6, 2008
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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