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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01350934
First received: May 9, 2011
Last updated: August 6, 2014
Last verified: August 2014

May 9, 2011
August 6, 2014
June 2011
January 2013   (final data collection date for primary outcome measure)
  • Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    BMD at the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) at baseline and Month 6.
  • Extension Study: Percentage Change From Baseline in Lumbar Spine BMD at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    BMD at the lumbar spine was assessed by DXA at baseline and Month 12.
  • 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 ]
Complete list of historical versions of study NCT01350934 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Extension Study: Percentage Change From Baseline in s-P1NP at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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.
  • Extension Study: Percentage Change From Baseline in s-CTx at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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.
  • 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 ]
Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
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.
Not Provided
 
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)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis, Postmenopausal
  • 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 orally
  • Dietary Supplement: Calcium 500 mg
    one 500 mg tablet once daily
  • 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).
    Interventions:
    • Drug: alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus)
    • Dietary Supplement: Calcium 500 mg
  • 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).
    Interventions:
    • Drug: Calcitriol
    • Dietary Supplement: Calcium 500 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
219
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Female
56 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01350934
0217A-264
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP