Clinical trial NCT01950169: Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture
Official title: Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Keywords: Hip fracture
Nutritional supplement
Bisphosphonates
Bone mineral density
Body composition
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 79
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.
timeFrame: Baseline, 6 months and 12 months
measure: Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture.
timeFrame: Baseline, 6 and 12 months
measure: Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture.
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Geriatric Medicine R94, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Margareta Hedström, MD, PhD
role: STUDY_DIRECTOR
affiliation: Karolinska Institutet
name: Maria Sääf, MD, PhD
role: STUDY_DIRECTOR
affiliation: Karolinska Institutet
name: Lena Flodin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flodin L, Cederholm T, Saaf M, Samnegard E, Ekstrom W, Al-Ani AN, Hedstrom M. Effects of protein-rich nutritional supplementation and bisphosphonates on body composition, handgrip strength and health-related quality of life after hip fracture: a 12-month randomized controlled study. BMC Geriatr. 2015 Nov 17;15:149. doi: 10.1186/s12877-015-0144-7.