Fracture incidence and changes in quality of life in women with an inadequate clinical outcome from osteoporosis therapy: the Observational Study of Severe Osteoporosis (OSSO).
In this observational study of women with an inadequate clinical outcome to osteoporosis therapy, those with a fracture at baseline were more likely to sustain an incident fracture and have a worse health-related quality of life than those without prior fracture.


BACKGROUND
The Observational Study of Severe Osteoporosis (OSSO) was designed to assess the fracture incidence and health-related quality of life (HRQoL) in women with an inadequate clinical outcome to osteoporosis therapy.


METHODS
Post-menopausal women (N=1,885) with established osteoporosis and an inadequate clinical response to osteoporosis drug therapy defined as: a) a fragility fracture despite therapy for one year (index fracture, N=988), or b) discontinued drug therapy due to adverse effects and/or non-compliance (N=897), were assessed during one year for HRQoL using the EQ-5D and the QUALEFFO questionnaires.


RESULTS
One hundred and sixty-six (8.8%) women had a total of 209 incident fractures (1,139 fractures/10,000 women-years). Women with an index fracture were more likely to sustain an incident fracture than those without prior fractures (hazard ratio 1.91; 95% CI: 1.37-2.66; p<0.001). Co-morbidities or antidepressant use at baseline also increased the risk of incident fracture. Median total EQ-5D Health State Values and QUALEFFO scores were worse in women with an incident fracture regardless of index fracture status. The worst scores were reported in the EQ-5D sub-domains of self-care, usual activities and pain/discomfort.


CONCLUSIONS
Women with an inadequate response to osteoporosis therapy had a high rate of incident fracture which had an adverse impact on HRQoL.
Cooper
C
C
MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK. cc@mrc.soton.ac.uk
Jakob
F
F
Chinn
C
C
Martin-Mola
E
E
Fardellone
P
P
Adami
S
S
Thalassinos
N C
NC
Melo-Gomes
J
J
Torgerson
D
D
Gibson
A
A
Marin
F
F
D000328:Adult; D000368:Aged; D015519:Bone Density / Q000502:physiology; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D050723:Fractures, Bone / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000503:physiopathology / Q000628:therapy*; D010349:Patient Compliance / Q000706:statistics & numerical data; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires; D017211:Treatment Failure; D016387:Women's Health
D050071:Bone Density Conservation Agents