Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
204 participants
INTERVENTIONAL
2005-01-31
2008-12-31
Brief Summary
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The study will provide new early rehabilitation guidelines to allocate health care resources efficiently in the acute care setting. Eventually and most importantly, the study will help improve outcomes in patients with hip fractures.
Detailed Description
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The researchers will enroll 204 elderly subjects (men and women) admitted to two large hospital centers 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 reach a Folstein Mini Mental Status of less than 15 are 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Interventions
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cholecalciferol
Physiotherapy
Eligibility Criteria
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Inclusion Criteria
* Acute hip fracture admitted to one hospital center
Exclusion Criteria
* 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 15 ml/min)
* Hypercalcemia (albumin adjusted) of more than 2.8 mmol/l
* non-surgical treatment
* no German language skills
* severe hearing or visual impairment
65 Years
ALL
No
Sponsors
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Swiss National Science Foundation
OTHER
Principal Investigators
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Heike A Bischoff-Ferrari, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Robert Theiler, MD
Role: STUDY_DIRECTOR
Triemli Spital Zurich
Hannes B Staehelin, MD
Role: STUDY_CHAIR
University of Basel
Andreas Platz, MD
Role: STUDY_DIRECTOR
TriemliSpital
Locations
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Triemli Hospital
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Heike A Bischoff-Ferrari, MD, MPH
Role: primary
References
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Braendle K, Egli A, Bischoff-Ferrari H, Freystaetter G. Does living alone influence fall risk among Swiss older adults aged 60+? A pooled observational analysis of three RCTs on fall prevention. BMJ Open. 2024 May 20;14(5):e081413. doi: 10.1136/bmjopen-2023-081413.
Fischer K, Trombik M, Freystatter G, Egli A, Theiler R, Bischoff-Ferrari HA. Timeline of functional recovery after hip fracture in seniors aged 65 and older: a prospective observational analysis. Osteoporos Int. 2019 Jul;30(7):1371-1381. doi: 10.1007/s00198-019-04944-5. Epub 2019 Apr 2.
Nardi M, Fischer K, Dawson-Hughes B, Orav EJ, Meyer OW, Meyer U, Beck S, Simmen HP, Pape HC, Egli A, Willett WC, Theiler R, Bischoff-Ferrari HA. Association between Caregiver Role and Short- and Long-Term Functional Recovery after Hip Fracture: A Prospective Study. J Am Med Dir Assoc. 2018 Feb;19(2):122-129. doi: 10.1016/j.jamda.2017.08.009. Epub 2017 Sep 30.
Schaller F, Sidelnikov E, Theiler R, Egli A, Staehelin HB, Dick W, Dawson-Hughes B, Grob D, Platz A, Can U, Bischoff-Ferrari HA. Mild to moderate cognitive impairment is a major risk factor for mortality and nursing home admission in the first year after hip fracture. Bone. 2012 Sep;51(3):347-52. doi: 10.1016/j.bone.2012.06.004. Epub 2012 Jun 12.
Bischoff-Ferrari HA, Dawson-Hughes B, Platz A, Orav EJ, Stahelin HB, Willett WC, Can U, Egli A, Mueller NJ, Looser S, Bretscher B, Minder E, Vergopoulos A, Theiler R. Effect of high-dosage cholecalciferol and extended physiotherapy on complications after hip fracture: a randomized controlled trial. Arch Intern Med. 2010 May 10;170(9):813-20. doi: 10.1001/archinternmed.2010.67.
Other Identifiers
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NFP 53-405340-104845
Identifier Type: -
Identifier Source: secondary_id
405340-104845
Identifier Type: -
Identifier Source: org_study_id