A Multi-center, Randomized, Double-blind, Double-dummy Study in Postmenopausal Women With Low Bone Mineral Density to Compare the Effects of a Single Dose of i.v. Zoledronic Acid 5 mg, With Daily Oral Raloxifene 60 mg OD on Bone Turnover Markers
Overview
- Phase
- Phase 4
- Intervention
- Zoledronic acid
- Conditions
- Osteoporosis
- Sponsor
- Novartis
- Enrollment
- 110
- Locations
- 16
- Primary Endpoint
- Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Females, between 45 and 80 years (inclusive) of age, considered post-menopausal according to one of the following guidelines:
- •Cessation of menses for 18 months in women \< 50 years of age
- •Cessation of menses for 12 months in women age 50 years or over
- •Documented bilateral oophorectomy at least 1 year previously
- •Documented T score of less than or equal to -1.5 on dual energy X-ray absorptiometry (DXA) scan at the lumbar spine, total hip or femoral neck within 24 months prior to screening, and clinically indicated for treatment with bisphosphonates (BPs) for osteopenia or osteoporosis
- •Signed informed consent prior to initiation of any study procedure
Exclusion Criteria
- •Prior treatment with i.v. bisphosphonates within the last 2 years
- •Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks\*).
- •\*NOTE: If used less than 8 weeks, the washout period is 6 months.
- •Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization.
- •Any treatment with strontium renalate, sodium fluoride or parathyroid hormone
- •Use of systemic high dose corticosteroids at an average dose of ≥ 7.5 mg per day of oral prednisone or equivalent for a period of three months or more within the previous year
- •Treatment with any investigational drug within 30 days prior to randomization
- •Any woman of child bearing potential
- •Patients with fractures occurring within three months prior to randomization
- •History of hypersensitivity to bisphosphonates
Arms & Interventions
Zoledronic Acid
Zoledronic acid 5 mg (single i.v. infusion) + daily oral placebo for 6 months (zoledronic acid group)
Intervention: Zoledronic acid
Zoledronic Acid
Zoledronic acid 5 mg (single i.v. infusion) + daily oral placebo for 6 months (zoledronic acid group)
Intervention: Placebo oral pills
Raloxifene
Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
Intervention: Raloxifene
Raloxifene
Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
Intervention: Placebo intravenous (i.v.) infusion
Outcomes
Primary Outcomes
Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)
Time Frame: Baseline and 6 months
The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.
Secondary Outcomes
- Change From Baseline in Urine NTx at 2 Months(Baseline and 2 months)
- Change From Baseline in Urine NTx at 4 Months(Baseline and 4 months)
- Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months(Baseline and 2 months)
- Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months(Baseline and 4 months)
- Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months(Baseline and 6 months)
- Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire(Immediately after infusion procedure)
- Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire(Immediately after infusion procedure)
- Overall Patient Satisfaction Assessed by Satisfaction Questionnaire(Immediately after infusion procedure)
- Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens(At 6 month visit)