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Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

NCT01950169 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2021-04-14

Study results available
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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.

Conditions

  • Hip Fracture

Interventions

DRUG

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.

OTHER

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

Principal Investigators

  • Margareta Hedström, MD, PhD · Karolinska Institutet

  • Maria Sääf, MD, PhD · Karolinska Institutet

  • Lena Flodin, MD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01950169 on ClinicalTrials.gov