Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density
- Conditions
- Osteoporosis
- Interventions
- Drug: Placebo oral pillsDrug: Placebo intravenous (i.v.) infusion
- Registration Number
- NCT00431444
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 110
- 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
- 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
- History of non-traumatic uveitis or iritis, within 2 years prior to study entry.
- A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed.
- Previous major solid organ transplant recipient or on a transplant waiting list
- History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis
- Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months
- Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial
- Active dental infection, unhealed dental extraction or planned oral surgery within 3 month prior to randomization.
- Calculated creatinine clearance < 30 mL/min
- Greater than 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart).
- Serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.08 mmol/L (8.3 mg/dL) at screening
- AST, ALT or serum alkaline phosphatase greater than twice the upper limit of normal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Raloxifene Raloxifene Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group) Zoledronic Acid Zoledronic acid Zoledronic acid 5 mg (single i.v. infusion) + daily oral placebo for 6 months (zoledronic acid group) Zoledronic Acid Placebo oral pills Zoledronic acid 5 mg (single i.v. infusion) + daily oral placebo for 6 months (zoledronic acid group) Raloxifene Placebo intravenous (i.v.) infusion Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
- Primary Outcome Measures
Name Time Method Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) 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 Outcome Measures
Name Time Method Change From Baseline in Urine NTx at 2 Months Baseline and 2 months The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.
Change From Baseline in Urine NTx at 4 Months Baseline and 4 months The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.
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 The investigator was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."
Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire Immediately after infusion procedure The study coordinator (nurse) was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."
Overall Patient Satisfaction Assessed by Satisfaction Questionnaire Immediately after infusion procedure Patients were asked to complete the satisfaction questionnaire at baseline. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."
Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens At 6 month visit At the end-of-study visit, Month 6, patients were asked to complete a questionnaire to assess preference for the different treatment modalities (annual i.v. infusion vs. daily oral capsule). The possible answers to question were: "once a year i.v. infusion," "once daily pill," or "both are equal."
Trial Locations
- Locations (16)
Women's Health Research
🇺🇸Phoenix, Arizona, United States
Alegent Health
🇺🇸Omaha, Nebraska, United States
UMDNJ-Robert Wood Johnson Medical Center
🇺🇸New Brunswick, New Jersey, United States
Specialty Medical and Research Center
🇺🇸Pahrump, Nevada, United States
Women's Physicians of Jacksonville
🇺🇸Jacksonville, Florida, United States
The Portland Clinic
🇺🇸Portland, Oregon, United States
Texas Institute for Clinical Research
🇺🇸Fort Worth, Texas, United States
Kernodle Clinic, Inc.
🇺🇸Burlington, North Carolina, United States
Consultants in Women's Health Care
🇺🇸St Louis, Missouri, United States
Columbia University
🇺🇸New York, New York, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Valley Women's Health Clinic
🇺🇸Renton, Washington, United States
Tampa Clinical Research
🇺🇸Tampa, Florida, United States
Associated Pharma Research Center
🇺🇸Buena Park, California, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States