The aim of this study is to compare a low versus high intensity physiotherapy early rehabilitation program combined with a low versus high dose vitamin D early rehabilitation program in a randomized controlled trial among elderly patients with acute hip fracture in an acute care setting. The primary outcome to be compared between treatment arms is the rate of falls during a 12-month follow-up. Secondary outcomes are injurious falls, number of persons who fell, low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia), disability, quality of life (Euro-Qol), mortality and health care utilization. Another secondary outcome will be admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture. Admission to nursing home is the marker of loss of independence for the individual, but also triggers high cost for the society.

The study will provide new early rehabilitation guidelines to allocate health care resources efficiently in the acute care setting. Eventually and most importantly, our study will help improve outcomes in patients with hip fractures.

Condition	Intervention	Phase
Accidental Falls Fractures Disability	Drug: cholecalciferol  Behavior: Physiotherapy	Phase III

Further Study Details: 

Primary Outcomes: Rate of falls compared between treatment arms
Secondary Outcomes: - rate of injurious falls; - number of persons who fell; - low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia); - disability; - quality of life (Euro-Qol); - mortality; - health care utilization; - admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture
Expected Total Enrollment:  240

Subjects:

We will enroll 240 elderly subjects (men and women) admitted to two large hospital center with acute hip fracture. Subjects may be institutionalized or community-dwelling prior to admission. To be enrolled in the study subjects need to be 65 years or older. Demented persons, who are at a high risk for falling are not excluded.

Design:

Once written informed consent from participants or proxies is given, subjects will be randomly assigned to 4 different program combinations based on a 2X2 factorial design: (1) low dose vitamin D / low intensity physiotherapy; or (2) low dose vitamin D / high intensity physiotherapy; or (3) high dose vitamin D / low intensity physiotherapy; or (4) high dose vitamin D / high intensity physiotherapy.Low dose Vitamin D is 800 IU cholecalciferol per day and high dose vitamin D is 2000 IU cholecalciferol per day.

Subjects will be recruited within 5 days after hip fracture surgery and followed for adverse outcomes over a 12-month period. Dose of vitamin D will be double-blinded.

Ages Eligible for Study:  65 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age 65 years or older
• Acture hip fracture admitted to one hospital center

Exclusion Criteria:

• A Folstein Mini Mental Score of less than 15 as an indicator of significant dementia
• Primary hyperparathyroidism
• Current cancer with wasting or bone metastases
• Hyperparathyroidism
• Sarcoidosis
• A kidney stone in the past 5 years or significant renal disease (creatinine clearance below 30 ml/min)

Please refer to this study by ClinicalTrials.gov identifier  NCT00133640

Heike A Bischoff-Ferrari, MD, MPH      +41-44-2552699    Heike.Bischoff@usz.ch

Switzerland
      Triemli Hospital, Zurich,  8063,  Switzerland; Recruiting

Study chairs or principal investigators

Heike A Bischoff-Ferrari, MD, MPH,  Principal Investigator,  University Hospital Zurich   
Robert Theiler, MD,  Study Director,  Triemli Spital Zurich   
Hannes B Staehelin, MD,  Study Chair,  University Hospital, Basel, Switzerland   
Andreas Platz, MD,  Study Director,  TriemliSpital   

Study ID Numbers:  405340-104845; NFP 53-405340-104845
Last Updated:  August 22, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00133640
Health Authority: Switzerland: Swissmedic
ClinicalTrials.gov processed this record on 2005-08-23