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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692913
• Other study ID #: 0217A-262
• Secondary ID: 2007_653
• Status: Completed
• Phase: Phase 3
• Start date: June 2008
• Est. completion date: July 2010

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at 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.	Week 26
Secondary	Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio	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.	Baseline and Week 26
Secondary	Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase	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.	Baseline and Week 26
Secondary	Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at 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.	Week 52
Secondary	Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density	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.	Baseline and Week 52
Secondary	Falls Per Participant	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.	Up to Week 52
Secondary	Percent Change From Baseline at Week 52 in 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 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.	Baseline and Week 52
Secondary	Percent Change From Baseline at Week 52 in 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 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.	Baseline and Week 52