- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01350934
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)
April 17, 2024 updated by: Organon and Co
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
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.
Study Overview
Status
Completed
Conditions
Detailed Description
This was 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 plus vitamin D3 5600 IU combination tablets versus calcitriol in the treatment of osteoporosis in postmenopausal women in China.
Participants were randomly assigned to receive alendronate 70 mg plus vitamin D3 5600 IU combination tablet once weekly orally or calcitriol 0.25 μg daily orally.
Study Type
Interventional
Enrollment (Actual)
219
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
54 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fosamax Plus
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
one combination tablet once weekly
Other Names:
one 500 mg tablet once daily
|
Active Comparator: Calcitriol
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
one 500 mg tablet once daily
0.25 μg once daily orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6
Time Frame: Baseline and Month 6
|
BMD at the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) at baseline and Month 6.
|
Baseline and Month 6
|
Extension Study: Percentage Change From Baseline in Lumbar Spine BMD at Month 12
Time Frame: Baseline and Month 12
|
BMD at the lumbar spine was assessed by DXA at baseline and Month 12.
|
Baseline and Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Base Study: Percentage Change From Baseline in Serum Procollagen Type 1 N-Terminal Propeptide (s-P1NP) at Month 6
Time Frame: Baseline and Month 6
|
s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body.
s-P1NP was measured at baseline and Month 6.
|
Baseline and Month 6
|
Base Study: Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 6
Time Frame: Baseline and Month 6
|
s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body.
s-CTx was measured at baseline and Month 6.
|
Baseline and Month 6
|
Extension Study: Percentage Change From Baseline in s-P1NP at Month 12
Time Frame: Baseline and Month 12
|
s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body.
s-P1NP was measured at baseline and Month 12.
|
Baseline and Month 12
|
Extension Study: Percentage Change From Baseline in s-CTx at Month 12
Time Frame: Baseline and Month 12
|
s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body.
s-CTx was measured at baseline and Month 12.
|
Baseline and Month 12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12
Time Frame: Baseline and Month 12
|
The term "vitamin D insufficiency" is used to describe vitamin D levels that are low enough to cause secondary hyperparathyroidism, bone loss, and increased risk of skeletal fracture.
In this study, a threshold for vitamin D insufficiency was a level of serum 25(OH) D <20 ng/mL.
|
Baseline and Month 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 19, 2011
Primary Completion (Actual)
January 10, 2013
Study Completion (Actual)
January 10, 2013
Study Registration Dates
First Submitted
May 9, 2011
First Submitted That Met QC Criteria
May 9, 2011
First Posted (Estimated)
May 10, 2011
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- Osteoporosis, Postmenopausal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Micronutrients
- Membrane Transport Modulators
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vasoconstrictor Agents
- Calcium Channel Agonists
- Vitamin D
- Cholecalciferol
- Calcium
- Alendronate
- Calcitriol
Other Study ID Numbers
- 0217A-264
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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