Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

Hip Fracture Clinical Trial

Official title:

Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950169
• Other study ID #: NutristudienSHFG
• Status: Completed
• Phase: N/A
• Start date: December 2004
• Est. completion date: May 2009

Study information

• Verified date: September 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Geriatric Medicine R94, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.	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
Primary	Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.	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	Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture.	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
Secondary	Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture.	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