Phase 4
N=109
Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00431444 ↗Enrolled (actual)
109
Serious AEs
1.8%
Results posted
Mar 2011
Primary outcome: Primary: Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) — 49.054; 44.460; 23.676; 34.183 nM BCE/mM Cr
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Raloxifene (Drug); Zoledronic acid (Drug); Placebo oral pills (Drug); Placebo intravenous (i.v.) infusion (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Novartis
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) |
49.054; 44.460; 23.676; 34.183; -24.646; -8.362 | — |
| SECONDARY Change From Baseline in Urine NTx at 2 Months |
49.054; 44.460; 17.774; 40.756; -31.065; -4.000 | — |
| SECONDARY Change From Baseline in Urine NTx at 4 Months |
49.054; 44.460; 20.802; 38.143; -27.832; -3.920 | — |
| SECONDARY Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months |
30.104; 27.094; 20.855; 26.424; -8.947; -1.085 | — |
| SECONDARY Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months |
30.104; 27.094; 18.218; 25.111; -11.442; -2.000 | — |
| SECONDARY Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months |
30.104; 27.094; 19.237; 24.981; -10.572; -2.250 | — |
| SECONDARY Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire |
0; 0; 3; 1; 2; 3 | — |
| SECONDARY Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire |
0; 0; 4; 3; 29; 35 | — |
| SECONDARY Overall Patient Satisfaction Assessed by Satisfaction Questionnaire |
1; 1; 0; 1; 1; 1 | — |
| SECONDARY Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens |
47; 46; 3; 4; 3; 3 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00431444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.