Objectives: To assess safety and clinical efficacy during 134 parathyroid hormone treatment (134-PTH) in real clinical practice; to describe fracture outcome after 134-PTH discontinuation in real clinical practice.
Methods: We performed an observational study in real clinical practice of all consecutive severe osteoporosis (sOP) patients referred to our Rheumatology Department from Feb10 until Jan14. All patients were referred both by general practitioners and geriatrists from a 150 000 population community (Hospitalet Llobregat). Patients were classified as sOP if they accomplished one of the following: incidental osteoporotic fractures during previous anti-OP treatment, need of chronic systemic steroid treatment and presence of previous osteoporotic fracture, several previous osteoporotic fractures, and serious risk of fall with previous osteoporotic fracture. 134-PTH was given to all of them. The incidence of clinical vertebral and nonvertebral fragility fractures were assessed, and fractures outcome were asked in 6-month-follow-up visits. All safety issues were registered in a questionnaire-sheet. A 12-month vertebral X-ray was performed during treatment, and blood tests (assessing bone metabolism and renal function after 134-PTH treatment) and previous-BMD were collected. All data concerning to age, 134-PTH onset/discontinuation, previous treatment, number of fractures, side-effects, incidental fractures and fractures outcome were registered in a database.
Results: A total of 111 patients fulfilled our sOP criteria. All patients showed OP-BMD level. 83% retained an 18-month course of 134-PTH. 17 patients discontinued treatment due to a mild side-effects (12 by GI intolerance, four by headache, and one site-injection pain), all recovered. No serious side-effects were found. A total of 79.8% were women, mean age 71.3 (S.D.±6.7), 38% had one previous fracture (63% vertebral, 19% hip, and 18% others), and 62% greater than or equal to one previous fracture; mean number of fractures was 1.94 (S.D.±1.49). The 38% had suffered fracture during previous treatment (95% on byphosphonates). No new fractures were observed during treatment follow-up. Fifty-four (57%) had finished the 18-month course 134-PTH (mean follow-up 9.2 months; S.D.±2.4). Of these, three patients showed one each new vertebral fractures (5.2%) after 134-PTH discontinuation.
Conclusions: 134 PTH showed benefit during treatment and a very low rate of fracture after its discontinuation in sOP in real clinical practice. Safety issues were mild and fully recovered, and observed in only 15% of patients. Longer follow-up time is needed to elucidate post-134 PTH fracture outcome. These results should be interpreted in the context of the design of an observational study.
17 May 2014 - 20 May 2014