Osteoporosis and Knee Insufficiency Fracture

NCT02332681 | Unknown DMC

• 1 other identifier: 38151514.8.0000.5404
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoporosis is a systemic bone disease characterized by low bone mass and microarchitectural deterioration of bone tissue with consequent bone fragility and susceptibility to fracture. Fifty percent of women and 20% men older than 50 y.o. will have an osteoporotic fracture (fragility fracture). Fragility fracture is defined as one that results from a low-energy trauma such as a fall from body height. A previous fracture is an important predictor of a new fracture, especially in the first 5 years after initial fracture. A second fracture can be particularly devastating if it is a hip fracture. Low bone mineral density, measured by bone densitometry, as well as a previous osteoporotic fracture, are the two major risk factors for the occurrence of a new fracture. A more rational approach currently used to minimize the costs of health care in a shorter period of time uses the strategy of firstly preventing the occurrence of secondary fracture, followed by primary prevention strategies. In this context, correct identification of fragility fractures and consequent treatment of those individuals is imperative. There are currently insufficient data about the epidemiology and evolution of other fragility fractures, also known as non-vertebral non-hip fracture (NVNH). Among these, distal radius fracture and proximal humerus fractures are the most frequent. There is a type of fracture, however, that is simply ignored by the medical community: the knee insufficiency fracture.A possible explanation for this information gap could be the fact that, until a few years ago, this entity was believed to be a osteonecrosis of the knee. Only recently it is becoming clear that the cause of pain and marrow bone edema that occur subtly in older individuals is, in fact, a insufficiency fracture. The perception that this lesion is actually a fracture is relatively new. The knee insufficiency fracture usually occurs in older individuals and those with knee osteoarthritis. This study therefore aims to evaluate whether there is a relation between knee insufficiency fracture and osteoporosis. Moreover, it is expected to find out if this fracture may be defined as a fragility fracture, electing the individuals affected by it to a prophylaxis for the occurrence of new osteoporotic fracture.

Conditions

Osteoporosis; Osteoporotic Fractures; Osteonecrosis

Outcome Measures

Primary Outcomes (1)

• New fracture

  Occurrence of a new fragility fracture

  12 months

Secondary Outcomes (1)

• Bone Mineral Density

  12 months

Study Arms (2)

With insufficiency fracture

Patients with acute pain that sustained a knee insufficiency fracture

Without insufficiency fracture

Patients with acute pain that did not sustained a knee insufficiency fracture

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients older than 45 years, with sudden joint line knee pain without high trauma history, with or without a history of osteoarthritis and / or osteoporosis.

You may qualify if:

• patients who seek orthopedics service with sudden onset of pain in the knee;
• age of 45 y.o. or more
• acceptance by signing the informed consent form.

You may not qualify if:

• acute trauma of knee
• other etiologies (post-traumatic, infectious, inflammatory diseases)
• pregnant women

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• University of Campinas, Brazil: collaborator

Study Sites (1)

University of Campinas

Campinas, São Paulo, 13083-888, Brazil

RECRUITING

Related Publications (5)

• Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R, Reginster JY; Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the Committee of Scientific Advisors of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2013 Jan;24(1):23-57. doi: 10.1007/s00198-012-2074-y. Epub 2012 Oct 19.

  PMID: 23079689 RESULT

• Kanis JA, Johnell O, Oden A, Sembo I, Redlund-Johnell I, Dawson A, De Laet C, Jonsson B. Long-term risk of osteoporotic fracture in Malmo. Osteoporos Int. 2000;11(8):669-74. doi: 10.1007/s001980070064.

  PMID: 11095169 RESULT

• van Staa TP, Dennison EM, Leufkens HG, Cooper C. Epidemiology of fractures in England and Wales. Bone. 2001 Dec;29(6):517-22. doi: 10.1016/s8756-3282(01)00614-7.

  PMID: 11728921 RESULT

• Bouxsein ML, Kaufman J, Tosi L, Cummings S, Lane J, Johnell O. Recommendations for optimal care of the fragility fracture patient to reduce the risk of future fracture. J Am Acad Orthop Surg. 2004 Nov-Dec;12(6):385-95. doi: 10.5435/00124635-200411000-00003.

  PMID: 15615504 RESULT

• Friedman SM, Mendelson DA. Fragility fractures. Clin Geriatr Med. 2014 May;30(2):xiii-xiv. doi: 10.1016/j.cger.2014.01.019. Epub 2014 Mar 4. No abstract available.

  PMID: 24721376 RESULT

MeSH Terms

Conditions

Osteoporosis; Osteoporotic Fractures; Osteonecrosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gustavo C Campos, Phd

  University of Campinas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustavo C Campos, Phd

CONTACT

+551983318000; gustavoccampos@terra.com.br

Alessandro R Zorzi, MsC

CONTACT

+551935217505; zorzi@fcm.unicamp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 7, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 7, 2015

Record last verified: 2014-12

Locations

BR (1)