N/A
Completed N=79
Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture
Source: ClinicalTrials.gov NCT01950169 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. — -0.008; 0.005; -0.017; -0.012 g/cm^2 — p=0.05
Summary
The study hypothesis is that nutritional supplementation together with bisphosphonates have a better preserving effect on bone mineral density (BMD) after hip fracture than bisphosphonates alone and that nutritional supplementation given postoperatively for 6 months preserve lean body mass in elderly hip fracture patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. |
-0.008; 0.005; -0.017; -0.012; -0.004; -0.018 | 0.05 |
| PRIMARY Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. |
-0.005; -0.006; -0.012; -0.003; 0.0006; -0.017 | 0.05 |
| SECONDARY Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture. |
-0.4; -0.9; -0.4; -0.5; -0.8; -0.5 | 0.05 |
| SECONDARY Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture. |
-0.6; 0.1; -0.1; -0.3; 0.1; -0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 60 years
- Recent fracture of the femoral neck or trochanter
- Without severe cognitive impairment
- Ambulant before fracture
- BMI ≤ 28
Exclusion Criteria
- Abnormal parameters regarding liver i.e. S-Alanine aminotransferase (S-ALAT) and S-Aspartate aminotransferase (S-ASAT) ≥ twice as normal
- Abnormal parameters regarding kidney i.e. S-Creatinine > 130 µg/L
- Primary hyperparathyroidism, osteogenesis imperfecta, Paget´s disease
- Myeloma
- Lactose intolerance
- Dysphagia
- Esophagitis
- Gastric ulcer
- Malignancy
- Diabetes with nephropathy or retinopathy
- Active iritis or uveitis
Data sourced from ClinicalTrials.gov (NCT01950169). 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. Informational only — not medical advice.