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)

NCT01350934 | Completed Phase 4 Results

• 1 other identifier: 0217A-264
• Study Type: interventional
• Target: 219
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (2)

• Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 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

  BMD at the lumbar spine was assessed by DXA at baseline and Month 12.

  Baseline and Month 12

Secondary Outcomes (4)

• Base Study: Percentage Change From Baseline in Serum Procollagen Type 1 N-Terminal Propeptide (s-P1NP) at 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

  Baseline and Month 6

• Extension Study: Percentage Change From Baseline in s-P1NP at Month 12

  Baseline and Month 12

• Extension Study: Percentage Change From Baseline in s-CTx at Month 12

  Baseline and Month 12

Other Outcomes (1)

• Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12

  Baseline and Month 12

Study Arms (2)

Fosamax Plus

EXPERIMENTAL

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).

Drug: alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus); Dietary Supplement: Calcium 500 mg

Calcitriol

ACTIVE COMPARATOR

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).

Drug: Calcitriol; Dietary Supplement: Calcium 500 mg

Interventions

alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus) DRUG

one combination tablet once weekly

Also known as: MK-0217A

Fosamax Plus

Calcitriol DRUG

0.25 μg once daily orally

Calcitriol

Calcium 500 mg DIETARY_SUPPLEMENT

one 500 mg tablet once daily

Calcitriol; Fosamax Plus

Eligibility Criteria

• Age: 56 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Zhang ZL, Liao EY, Xia WB, Lin H, Cheng Q, Wang L, Hao YQ, Chen DC, Tang H, De Peng Y, You L, He L, Hu ZH, Song CL, Wei F, Wang J, Zhang L, Santora AC. Alendronate sodium/vitamin D3 combination tablet versus calcitriol for osteoporosis in Chinese postmenopausal women: a 6-month, randomized, open-label, active-comparator-controlled study with a 6-month extension. Osteoporos Int. 2015 Sep;26(9):2365-74. doi: 10.1007/s00198-015-3141-y. Epub 2015 May 1.

  PMID: 25929192 RESULT

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Alendronate; Cholecalciferol; Calcitriol; Calcium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dihydroxycholecalciferols; Hydroxycholecalciferols; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharpe & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 10, 2011
• Study Start: June 19, 2011
• Primary Completion: January 10, 2013
• Study Completion: January 10, 2013
• Last Updated: June 20, 2024
• Results First Posted: July 22, 2014

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share