Characterization of patients with an inadequate clinical outcome from osteoporosis therapy: the Observational Study of Severe Osteoporosis (OSSO).
BACKGROUND
Osteoporotic fractures remain a major public health problem. Currently available osteoporosis therapies significantly reduce the risk of fractures, but up to 50% of patients have an inadequate clinical outcome to therapy.


OBJECTIVE
To describe the clinical and quality of life (QOL) of a study population meeting a proposed definition of inadequate clinical outcome to osteoporosis therapy, recruited for the Observational Study of Severe Osteoporosis (OSSO).


METHODS
Cross-sectional, observational study.


METHODS
Post-menopausal women with osteoporosis (n = 2314) were divided into Group 1 (those who had previously experienced a fragility fracture despite osteoporosis drug therapy for at least 12 months) (n = 1309, 57%), or Group 2 (those who had previously discontinued osteoporosis drug therapy due to non-compliance or side-effects) (n = 1005; 43%). Baseline clinical characteristics, quality of life (QOL) and osteoporosis/falls risk factors were analysed.


RESULTS
The overall population had low BMD (mean +/- SD T-score at lumbar spine -3.1 +/- 1.1), and risk factors for fracture such as previous fractures (67.8%), family history (15.1%), and prolonged glucocorticoid use (17.5%). QOL was poor: total QUALEFFO and EQ-5D scores were 46.8 +/- 18.7, and 0.50 +/- 0.33, respectively. Patients in Group 1 had higher age and body mass index, fewer hours of exercise, more previous fragility fractures and falls, and poorer QOL scores.


CONCLUSIONS
Our definition of inadequate clinical outcome from osteoporosis drug therapy identifies a severe osteoporosis cohort with poor QOL and increased fracture risk. Using such a definition may lead to earlier recognition of inadequate clinical outcome to osteoporosis therapy, and improved interventions and results.
Jakob
F
F
Orthopaedic Department, Julius-Maximilians-Universität, Wurzburg, Germany.
Marín
F
F
Martín-Mola
E
E
Torgerson
D
D
Fardellone
P
P
Adami
S
S
Thalassinos
N C
NC
Sykes
D
D
Melo-Gomes
J
J
Chinn
C
C
Nicholson
T
T
Cooper
C
C
D015502:Absorptiometry, Photon; D000058:Accidental Falls / Q000706:statistics & numerical data; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004812:Epidemiologic Methods; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy*; D010349:Patient Compliance / Q000706:statistics & numerical data; D011788:Quality of Life; D017584:Reproductive History; D017211:Treatment Failure
D050071:Bone Density Conservation Agents