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Completed

NCT Number: NCT01950169

Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

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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Key information

Conditions

Hip Fracture Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Geriatric Medicine R94, Karolinska University Hospital

Stockholm, SE-141 86, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

risedronate

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.

Other names: Bisphosphonate Group (B)

Nutritional Supplement

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.

Other names: Bisphosphonate and nutritional supplemented Group (BN)

Calcium and vitamin D3

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.

Other names: Control Group (C)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 25, 2013
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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