Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

Karolinska Institute

Status: Completed

Conditions: Hip Fracture

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01950169

NutristudienSHFG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 3 patient groups

Risedronate

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: Calcium and vitamin D3

Drug: Risedronate

Nutritional supplement

Active Comparator group

Description:

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)

Treatment:

Other: Nutritional supplement

Dietary Supplement: Calcium and vitamin D3

Drug: Risedronate

Calcium and vitamin D3

Active Comparator group

Description:

An oral dose of 1000 mg Calcium and 800 IU vitamin D3 daily for 12 months after hip fracture. Group C (control)

Treatment:

Dietary Supplement: Calcium and vitamin D3