CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 79 enrolled
Drug / intervention
Risedronate +2 moredrug
Likely dose
Risedronate 35 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01950169
NCT01950169N/ACompleted

Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

Karolinska Institutet·interventional·Posted Sep 25, 2013·Updated Apr 14, 2021

In Brief

A clinical study evaluating Risedronate, Nutritional supplement, and 1 other intervention for Hip Fracture. Completed, enrolled 79 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHip Fracture
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 25, 2013
Enrollment StartDec 1, 2004
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 12.8 years ago

Interventions

Risedronatedrug

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 supplementother

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 D3dietary

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