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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
Women's Health Research
Phoenix, Arizona, United States
Associated Pharma Research Center
Buena Park, California, United States
Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)
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.
Time frame: Baseline and 6 months
Change From Baseline in Urine NTx at 2 Months
The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.
Time frame: Baseline and 2 months
Change From Baseline in Urine NTx at 4 Months
The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.
Time frame: Baseline and 4 months
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months
Time frame: Baseline and 2 months
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months
Time frame: Baseline and 4 months
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months
Time frame: Baseline and 6 months
Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire
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."
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Unnamed facility
Washington D.C., District of Columbia, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Women's Physicians of Jacksonville
Jacksonville, Florida, United States
Tampa Clinical Research
Tampa, Florida, United States
Springfield Clinic
Springfield, Illinois, United States
Consultants in Women's Health Care
St Louis, Missouri, United States
Alegent Health
Omaha, Nebraska, United States
Specialty Medical and Research Center
Pahrump, Nevada, United States
...and 7 more locations
Time frame: Immediately after infusion procedure
Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire
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."
Time frame: Immediately after infusion procedure
Overall Patient Satisfaction Assessed by Satisfaction Questionnaire
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."
Time frame: Immediately after infusion procedure
Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens
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."
Time frame: At 6 month visit