Background Denosumab has become a useful parental therapy for the treatment of osteoporosis. FREEDOM extension study has shown safety and effectiveness of denosumab beyond 8 years. Real life data on the efficacy and safety of denosumab is lacking. There are no studies looking at the drug survival in the osteoporosis population either. Observational data from clinical practice can provide unique clinical perspective for novel therapies like denosumab.
Objectives 1. To look at the baseline characters of patients receiving denosumab in a secondary care unit in UK.
2. To study the drug survival rate, analyse the reasons for discontinuation of therapy.
3. To assess fractures during the course of denosumab therapy.
Methods We looked at the case records retrospectively of all the patients receiving denosumab therapy from 01/01/2011 to 31/12/2016. A database to record baseline characters, indications and previous fracture was prepared. Renal function, calcium, alkaline phosphatase (ALP), vitamin D levels at baseline and renal function, calium and ALP levels for each injection visit were noted. Vitamin D status was assessed at least once a year. Reasons to stop therapy were recorded.
Results 237 patients were offered the treatment. One patient declined the treatment at the beginning.
5 (2.1%) patients had fracture on treatment. 2 had a hip fracture and one of them had a previous fracture (humerus). Other fracture sites were ankle, humerus and metatarsal. None of them had any further fractures during the follow up period.
61 patients discontinued therapy during the course of treatment over 3 years. 8 (4.2%) had infections, 7 (3.6%) due to declining eGFR and 9 (4.7%) were lost to follow up. 1 patient had jaw necrosis after the first injection. 1 developed hepatitis after the first injection which resolved on withdrawal of therapy. 6 (3.1%) patients withdrew consent for therapy. 19 (8%) patients died causes unrelated to denosumab therapy. 23 (9.7%) patients moved away. Treatment was stopped due to other side effects in 3 patients (2 had rash and 1 headache). There were no episodes of hypocalcaemia.
Conclusions 1. Majority patients were elderly and female. Majority were high risk and had received osteoporosis treatments previously.
2. Denosumab therapy was well tolerated and nearly 2/3rd were stll receiving therapy at 3 years. Treatment was withdrawn due to an adverse event in only 14 (6%) patients.
3. Fracture rate was very low and there were no repeat or multiple fractures.
Pappapoulos S et al. The effect of 8 or 5 years of denosumab treatment in postmenopausal women with osteoporosis: results from the FREEDOM Extension study. Osteoporosis Int. 2015 Dec;26(12):2773–83.
Disclosure of Interest None declared