Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-05-31

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.

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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.

Conditions

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Hip Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Risedronate

Intervention Type DRUG

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.

Calcium and vitamin D3

Intervention Type DIETARY_SUPPLEMENT

The patients in the control group (C) receive orally administered calcium 1000 mg and 800 IU vitamin D3 (Calcichew-D3®) daily for 12 months.

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)

Group Type ACTIVE_COMPARATOR

Risedronate

Intervention Type DRUG

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.

Nutritional supplement

Intervention Type OTHER

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.

Calcium and vitamin D3

Intervention Type DIETARY_SUPPLEMENT

The patients in the control group (C) receive orally administered calcium 1000 mg and 800 IU vitamin D3 (Calcichew-D3®) daily for 12 months.

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)

Group Type ACTIVE_COMPARATOR

Calcium and vitamin D3

Intervention Type DIETARY_SUPPLEMENT

The patients in the control group (C) receive orally administered calcium 1000 mg and 800 IU vitamin D3 (Calcichew-D3®) daily for 12 months.

Interventions

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Risedronate

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.

Intervention Type DRUG

Nutritional supplement

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.

Intervention Type OTHER

Calcium and vitamin D3

The patients in the control group (C) receive orally administered calcium 1000 mg and 800 IU vitamin D3 (Calcichew-D3®) daily for 12 months.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Bisphosphonate Group (B) Bisphosphonate and nutritional supplemented Group (BN) Control Group (C)

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No