Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

Not Applicable

Completed

Interventions: Drug: Risedronate
Other: Nutritional supplement
Dietary Supplement: Calcium and vitamin D3

Brief 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.

Detailed Description: Inclusion criteria: Men and women, ≥ 60 years of age with a recent fracture of the femoral neck or trochanter, admitted to any of the four University hospitals in Stockholm, Sweden. Patients are randomized into three groups by sealed enveloped technique in blocks by 12, thus assuring that each center had an equal distribution of patients in the three treatment groups. Patients randomly assigned and followed for 12 months. Each center with a doctor in charge and a trial nurse. The trial nurse in collaboration with the doctor are responsible of the randomization procedure and that blood samples are taken in the morning of the first weekday after inclusion at the ward and further that the dual-energy X-ray (DXA) and all estimates are done during hospital stay.The pharmacological treatment and nutritional supplementation starts as soon as the patients are circulatory stable, able to take food by mouth and are able to sit in an upright position one hour after taking the tablets.Patients are examined at baseline with a follow up at 6 and 12 months.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Nutritional supplement	Calcium and vitamin D3	Oral liquid nutritional supplement (600kcal and 40 gram protein/day) for 6 months after the hip fracture besides Risedronate and calcium and vitamin D3. Group BN (bisphosphonate and nutritional supplemented group)
Calcium and vitamin D3	Calcium and vitamin D3	An oral dose of 1000 mg Calcium and 800 IU vitamin D3 daily for 12 months after hip fracture. Group C (control)
Risedronate	Calcium and vitamin D3	35 mg risedronate orally administered once weekly for 12 months and orally administered Calcium 1000 mg and 800 IU vitamin D3 daily for 12 months. Group B (bisphosphonate group)
Nutritional supplement	Nutritional supplement	Oral liquid nutritional supplement (600kcal and 40 gram protein/day) for 6 months after the hip fracture besides Risedronate and calcium and vitamin D3. Group BN (bisphosphonate and nutritional supplemented group)
Risedronate	Risedronate	35 mg risedronate orally administered once weekly for 12 months and orally administered Calcium 1000 mg and 800 IU vitamin D3 daily for 12 months. Group B (bisphosphonate group)
Nutritional supplement	Risedronate	Oral liquid nutritional supplement (600kcal and 40 gram protein/day) for 6 months after the hip fracture besides Risedronate and calcium and vitamin D3. Group BN (bisphosphonate and nutritional supplemented group)

Primary Outcome Measures

Name	Time	Method
Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.	Baseline, 6 months and 12 months	Total body mineral density (BMD) were assessed by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm\^2). The change in BMD between baseline, 6 and 12 months was registered.
Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.	Baseline, 6 months and 12 months	Total hip bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm\^2). The change in BMD between baseline, 6 and 12 months was registered.

Secondary Outcome Measures

Name	Time	Method
Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture.	Baseline, 6 and 12 months	Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up. The sum of lean mass (LM) and BMC represents fat-free mass (FFM). To normalize for body size, FFM was divided by height squared to calculate fat-free mass index (FFMI, kg/m\^2).
Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture.	Baseline, 6 and 12 months	Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up.To normalize for body size, FM was divided by height squared to calculate fat mass index (FMI, kg/m\^2).

Locations (1): Department of Geriatric Medicine R94, Karolinska University Hospital
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Stockholm, Sweden