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Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

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ClinicalTrials.gov Identifier: NCT01950169
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Lena Flodin, Karolinska Institutet

Brief 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.

Condition or disease Intervention/treatment Phase
Hip Fracture Drug: Risedronate Other: Nutritional supplement Dietary Supplement: Calcium and vitamin D3 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture
Study Start Date : December 2004
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Bisphosphonate Group (B)

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 Name: Bisphosphonate and nutritional supplemented Group (BN)

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 Name: Control Group (C)

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 Name: Control Group (C)




Primary Outcome Measures :
  1. Total hip bone mineral density (BMD) at 6 and 12 months after hip fracture. [ Time Frame: 12 months ]
    Total hip bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up.


Secondary Outcome Measures :
  1. Total body bone mineral density (BMD), lean and fat mass at 6 and 12 months after hip fracture. [ Time Frame: 12 months ]
    Total body composition measured by dual X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950169


Locations
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Sweden
Department of Geriatric Medicine R94, Karolinska University Hospital
Stockholm, Sweden, SE-141 86
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Study Director: Margareta Hedström, MD, PhD Karolinska Institutet
Study Director: Maria Sääf, MD, PhD Karolinska Institutet
Principal Investigator: Lena Flodin, MD Karolinska Institutet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lena Flodin, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01950169    
Other Study ID Numbers: NutristudienSHFG
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014
Keywords provided by Lena Flodin, Karolinska Institutet:
Hip fracture
Nutritional supplement
Bisphosphonates
Bone mineral density
Body composition
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Vitamin D
Ergocalciferols
Calcium, Dietary
Cholecalciferol
Risedronic Acid
Etidronic Acid
Diphosphonates
Vitamins
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action