A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264 AM1)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01350934

First received: May 9, 2011

Last updated: January 29, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	May 9, 2011
Last Updated Date	January 29, 2013
Start Date ^ICMJE	June 2011
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 9, 2011)	Percentage Change from Baseline in Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ] Percentage change from Baseline in Lumbar Spine BMD [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01350934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 9, 2011)	Percentage Change from Baseline in Procollagen 1 N-terminal Peptide (P1NP) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ] Percentage Change from Baseline in serum C-terminal Telopeptide (s-CTx) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ] Percentage Change from Baseline in P1NP [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ] Percentage Change from Baseline in s-CTx [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264 AM1)
Official Title ^ICMJE	A 6-Month, Randomized, Open-Label, Active-Comparator Controlled, Parallel-Group Study With a 6-Month Extension to Evaluate the Safety and Efficacy of Alendronate Sodium 70 mg/Vitamin D3 5600 I.U. Combination Tablets Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China
Brief Summary	This study will evaluate whether the once weekly administration of the combination tablet alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD) more than the daily use of calcitriol.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Osteoporosis, Postmenopausal
Intervention ^ICMJE	Drug: alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus) one combination tablet once weekly Other Name: MK-0217A Drug: Calcitriol 0.25 μg once daily Dietary Supplement: Calcium 500 mg one 500 mg tablet once daily
Study Arm (s)	Experimental: Fosamax Plus Interventions: Drug: alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus) Dietary Supplement: Calcium 500 mg Active Comparator: Calcitriol Interventions: Drug: Calcitriol Dietary Supplement: Calcium 500 mg
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	219
Completion Date	January 2013
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Meets one of the following BMD criteria: Has BMD T-score ≤-2.5 in at least one of the anatomic sites including lumbar spine, total hip, and femoral neck, OR Has prior non-pathological fragility fracture (of spine, wrist, humerus or clavicle) and BMD T-score ≤-1.5 in at least one of the anatomic sites including lumbar spine, total hip, and femoral neck sites Must have a baseline 25-hydroxyvitamin D ≥8 ng/mL (20 nmol/L) Is ambulatory Has been postmenopausal for at least one year Exclusion Criteria: Has any contraindication to alendronate, including abnormalities of the esophagus which delay esophageal emptying (such as stricture or achalasia), or inability to stand/sit upright for at least 30 minutes, or hypersensitivity to alendronate and vitamin D, or hypocalcemia Has any contraindications to calcitriol, and/or vitamin D, including hypercalcemia, hypercalciuria, or active kidney stone disease Had a prior hip fracture Has received treatment with any of the following: anabolic steroid agent within the past 12 months, systemic glucocorticoids for more than 2 weeks in the past 6 months, oral bisphosphonates more than 3 months within the past 2 years, any lifetime use of an intravenous administration of zoledronate, immunosuppressant other than methotrexate, fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks within the past 3 months, strontium containing products for more than 2 weeks within the past 6 months, Parathyroid hormone for more than 2 weeks within the past 3 months, current use of chemotherapy, or heparin, growth hormone for more than 2 weeks within the past 6 months, active hormonal vitamin D analogs (e.g., alphacalcidol, calcitriol) in the past 30 days, or more than 5 days treatment of active hormonal vitamin D analogs between 30 and 60 days prior to study entry., use of vitamin A (excluding beta carotene) >10,000 IU daily, unless willing to discontinue this dose during the study, current use of, lithium, or anti-convulsants, current use of calcium supplement in amount excess of 1500 mg daily, unless willing to discontinue this dose during the study, estrogen with or without progestin within the prior 6 months, Raloxifene or other selective estrogen receptor modulator ([SERM] including tamoxifen), tibolone, or an aromatase inhibitor within the prior 6 months and/or sub-cutaneous calcitonin or intra-nasal calcitonin within the prior 6 months Has a history of malignancy within previous 5 years Has one or more of the following concomitant conditions: uncontrolled upper gastrointestinal disorders, myocardial infarction, unstable angina, stroke and revascularization condition within 3 months, malabsorption syndrome, uncontrolled primary or secondary hyperparathyroidism, uncontrolled thyroid disease, renal insufficiency, uncontrolled genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, neurological, psychiatric, or pulmonary diseases; unexplained laboratory test abnormality or other conditions, uncontrolled hypertension, new onset diabetes (within 3 months), poorly controlled hyperglycemia or abnormal fasting glucose, hypoglycemia for any cause, history of, or evidence for metabolic bone disease other than osteoporosis, abnormal serum calcium or phosphate, and/or active renal stone disease when a calcium supplement is contraindicated
Gender	Female
Ages	56 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01350934
Other Study ID Numbers ^ICMJE	MK-0217A-264
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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