Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

Conditions
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Hip Fracture

Intervention / Treatment
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* Drug: Risedronate
* Other: Nutritional supplement
* Dietary Supplement: Calcium and vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Risedronate<br>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) | Drug: Risedronate<br>* The bisphosphonate group (B) receive 35 mg risedronate (Optinate® Septimum) once weekly for 12 months and calcium (1000 mg) and vitamin D3 (800 IU) (Calcichew-D3®) daily for 12 months.<br>* Other names: Bisphosphonate Group (B);Dietary Supplement: Calcium and vitamin D3<br>* The patients in the control group (C) receive orally administered calcium 1000 mg and 800 IU vitamin D3 (Calcichew-D3®) daily for 12 months.<br>* Other names: Control Group (C);|
| Active Comparator: Nutritional supplement<br>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) | Drug: Risedronate<br>* The bisphosphonate group (B) receive 35 mg risedronate (Optinate® Septimum) once weekly for 12 months and calcium (1000 mg) and vitamin D3 (800 IU) (Calcichew-D3®) daily for 12 months.<br>* Other names: Bisphosphonate Group (B);Other: Nutritional supplement<br>* The bisphosphonate and nutritional supplemented group (BN) receive 35 mg risedronate once weekly for 12 months plus nutritional supplement (Fresubin® protein energy drink) during the first six months following hip fracture and also calcium (1000 mg) and vitamin D3 (800 IU) daily for 12 months.<br>* Other names: Bisphosphonate and nutritional supplemented Group (BN);Dietary Supplement: Calcium and vitamin D3<br>* The patients in the control group (C) receive orally administered calcium 1000 mg and 800 IU vitamin D3 (Calcichew-D3®) daily for 12 months.<br>* Other names: Control Group (C);|
| Active Comparator: Calcium and vitamin D3<br>An oral dose of 1000 mg Calcium and 800 IU vitamin D3 daily for 12 months after hip fracture. Group C (control) | Dietary Supplement: Calcium and vitamin D3<br>* The patients in the control group (C) receive orally administered calcium 1000 mg and 800 IU vitamin D3 (Calcichew-D3®) daily for 12 months.<br>* Other names: Control Group (C);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | 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. | Baseline, 6 months and 12 months | 
| Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | 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. | Baseline, 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture. | 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). | Baseline, 6 and 12 months | 
| Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture. | 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). | Baseline, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip fracture, Nutritional supplement, Bisphosphonates, Bone mineral density, Body composition