Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

March 20, 2021 updated by: Lena Flodin, Karolinska Institutet
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, SE-141 86
        • Department of Geriatric Medicine R94, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
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 Names:
  • Bisphosphonate Group (B)
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.
Other Names:
  • Control Group (C)
Active Comparator: 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)
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 Names:
  • Bisphosphonate Group (B)
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.
Other Names:
  • Control Group (C)
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.
Other Names:
  • Bisphosphonate and nutritional supplemented Group (BN)
Active Comparator: 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)
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.
Other Names:
  • Control Group (C)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Study Director: Maria Sääf, MD, PhD, Karolinska Institutet
  • Principal Investigator: Lena Flodin, MD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

March 20, 2021

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NutristudienSHFG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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