Osteoporosis clinical trials endpoints: candidate variables and clinimetric properties.
We reviewed evidence on endpoints used in osteoporosis clinical trials to assist in the development of a set of endpoints to be included in all trials. A MEDLINE search was conducted using the Cochrane Collaboration strategy for each endpoint. Additional published literature was obtained from content experts. A proposed list of endpoints was developed after consultation with experts in the field. Each endpoint was evaluated with respect to validity, reproducibility, redundancy, and feasibility. We classified the endpoints into 2 major categories: clinical health status outcomes and intermediate endpoints, and for each endpoint we present current evidence from the literature as pertains to defined methodologic criteria. Multiple endpoints have been used in osteoporosis clinical trials, and an agreement on a core set of measures needs to be evidence based with an emphasis on validity, reproducibility, and feasibility and to satisfy clinical credibility.
Cranney
A
A
Department of Medicine, University of Ottawa, Canada.
Tugwell
P
P
Cummings
S
S
Sambrook
P
P
Adachi
J
J
Silman
A J
AJ
Gillespie
W J
WJ
Felson
D T
DT
Shea
B
B
Wells
G
G
D015415:Biomarkers; D015519:Bone Density; D002986:Clinical Trials as Topic; D003094:Collagen / Q000378:metabolism; D006801:Humans; D010024:Osteoporosis / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D011788:Quality of Life; D016103:Spinal Fractures / Q000473:pathology / Q000503:physiopathology; D016896:Treatment Outcome
D015415:Biomarkers; D003094:Collagen