Archives of Gerontology and Geriatrics 49 (2009) 35–38 Contents lists available at ScienceDirect Archives of Gerontology and Geriatrics journal homepage: www.elsevier.com/locate/archger Changes of the quality-of-life under the treatment of severe senile osteoporosis with teriparatide Domenico Maugeri a,*, Enzo Russo b, Salvatore Luca a, Carmelo Leotta a, Grazia Mamazza a, Rosaria Sorace a, Maurizio Rizzotto a, Sara Manuele a, Valentina Fiore a, Giuseppe Taverna a, Biagio Castiglia a, Michele Calitro c a Department of Aging, Urological and Neurological Sciences, University of Catania, Cannizzaro Hospital, Via Messina 829, I-95126 Catania, Italy b Unita` Operativa Complessa di Geriatria e Lungodegenza di Patti, Via Mazzini, I-98066 Patti (Messina), Italy c Unita` Operativa Complessa di Geriatria, Ospedale Civile Caduti il Guerra Via Bovio, I-70053 Canosa di Puglia (Bari), Italy ARTICLE INFO ABSTRACT Article history: Despite being treated with antiresorptive drugs, the severe osteoporosis (SO) is being considered as a Received 12 December 2007 condition in which patients are still subject to one or more vertebral or femoral fractures, or non- Received in revised form 18 April 2008 vertebral or non-femoral fractures, i.e., of other parts of the body such as the wrist, shoulder, tibia, ribs or Accepted 22 April 2008 hip. These patients are defined as non-responders (NRs) to the antiresorptive therapy, and recent Available online 13 June 2008 research has shown that they represent 10–25% of all SO patients. During the last almost 3 years a new drug has become available in Italy, called teriparatide (rh-PTH-1-34), produced in Escherichia coli using Keywords: the recombinant-DNA technique. It shows remarkable trophic and anabolic actions on the bones, and Severe senile osteoporosis Osteoporotic fractures proved to be very useful for treating the osteoporosis in general. This study describes our experience in Teriparatide using teriparatide for the treatment of SO in a sample of 141 elderly women of mean age 73.4 Æ 5.8 years, QoL with a mean number of fractures of 3.0 Æ 0.85, with a spine deformity index (SDI) of 5.92 Æ 1.27 and a mean QUALEFFO-test vertebral T-Score (L1–L4) of À3.15 Æ 0.39, and a mean femoral T-Score of À2.50 Æ 0.28. All these patients had been treated with antiresorptive drugs for at least 1 year: specifically 70 of them with Alendronate, 42 of them with Risedronate and 29 of them with Raloxifene. For 18 months, all these patients were injected subcutaneously with 20 mg of teriparatide, with the daily addition of 1 g of calcium and 880 IU of vitamin D. The study was continued for 24 months, at the end of which the patients continued to take only calcium and vitamin D. The patients underwent a CBM-DEXA control of vertebral column and femur every 6 months, and they were also administered a Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). The QUALEFFO (41 items) questionnaire to evaluate the changes in the quality-of-life (QoL) and the consumption of non-steroidal anti-inflammatory drugs (NSAIDs) was also recorded. The results showed that teriparatide protected 96.5% against new fractures (only five new fractures occurred), bone mineral density (BMD) increased approximately by 12% in the vertebral column and by 11% in the femur, consumption of NSAIDs was reduced at the early stage approximately 80%, the QoL improved considerably and remained so during the 18 months of teriparatide treatment, with only a slight decrease during the 6 subsequent months. ß 2008 Elsevier Ireland Ltd. All rights reserved. 1. Introduction subcutaneously once a day in doses of 20 mg(Dempster et al., 1991; Rubin et al., 2002). The teriparatide (1–34 fraction of PTH, produced by E. coli by The fraction prevention trial (FPT) carried out on 1637 women using the recombinant DNA technique) has become available in with post-menopausal osteoporosis demonstrated the unequi- Italy since about 3 years, and was used for the treatment of post- vocal effectiveness and safety of this drug when administered for menopausal osteoporosis and, more recently, also for male 18 months; bone protection was considerable and there was a osteoporosis. Teriparatide has a remarkable anabolic action on marked reduction in vertebral and femoral fractures as well as in the bone and improves its microarchitecture, if administered non-vertebral and non-femoral fractures (radius, humerus, tibia, etc.) (Neer et al., 2001). Bone-protection was maintained 2–3 years after the suspension of treatment (Jonsson et al., 1999). Moreover, * Corresponding author. Tel.: +39 095 7262 489 fax: +39 095 7262 487/9. on a smaller sample of patients with male osteoporosis, bone E-mail address: [email protected] (D. Maugeri). protection was also confirmed, but the BMD began to decrease 0167-4943/$ – see front matter ß 2008 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.archger.2008.04.008 36 D. Maugeri et al. / Archives of Gerontology and Geriatrics 49 (2009) 35–38 Table 1 Comparison of the main parameters of the study pool during the teriparatide treatment (mean Æ S.D.) Parameter T0 T6 T12 T18 T24 L1–L4 T-Score À3.15 Æ 0.39 nm À2.90 Æ 0.15 À2.80 Æ 0.22 À2.76 Æ 0.20 % change À7.9 À11.1 À12.4 BMD (mg/cm2) 593 Æ 58 nm 647 Æ 54 659 Æ 52 665 Æ 52 % change +8.4 +11.1 +12.1 Femur in toto T-Score À2.50 Æ 0.28 nm À2.40 Æ 0.44 À2.32 Æ 0.62 À2.22 Æ 0.56 % change À4.0 À7.2 À11.2 BMD (mg/cm2) 600 Æ 62 nm 625 Æ 54 645 Æ 62 668 Æ 58 % change +4.2 +7.5 +11.3 QUALEFFO-test 478 Æ 60 392 Æ 52 285 Æ 37 192 Æ 37 249 Æ 50 % change À18.0 À40.0 À60.0 À48.0 Use of NSAIDs in 141 patients n of patients 131 50 40 30 32 % of them 93.0 35.0 28.0 21.0 23.0 Note: nm, not measured again when the treatment was suspended (Bilezikian and Kurland, In one of our previous studies (Manuele et al., 2007)wehave 2001). already verified that teriparatide immediately and unequivocally In 2006, Boonen et al. (2006), on a group of 244 patients over the improves the QoL of patients, while protecting the fragile age of 75 years confirmed the effectiveness of teriparatide: osteoporotic skeleton. In addition to assessing the anti-osteo- vertebral and femoral BMD increased by 9.2% and 1.9%, respec- porotic efficacy of teriparatide in the traditional sense (reduction tively, after a 12-month treatment. These changes of bone mass of new fractures, increase in BMD), our research also aimed at were similar to those of a group of 841 control patients under the evaluating the effect on the QoL of elderly patients suffering from age of 75 (+9.1% and 2.9%, respectively): Boonen et al. (2006) SO, during the permitted 18-month cycle of treatment and concluded, therefore, that the effectiveness of teriparatide was not during the subsequent 6 months after the treatment was age-related and applied to all age groups. suspended. The same can be said regarding the safety of teriparatide, in so far as similar results were achieved in patients over and under 75 years of age, showing the same side effects, such as nausea, leg 2. Patients and methods cramps and dizziness. However, apart from its greater effective- Our study pool consisted of 141 elderly female patients with SO, treated at our ness in terms of reducing the number of new fractures, by giving centers in Catania, Canosa and Patti. Their mean age was 73.4 Æ 5.8 years and they over 65% total protection, what brings teriparatide in pole position had been treated for at least 1 year with antiresorptive drugs (70 of them with among the drugs used to treat osteoporosis is its considerable Alendronate, 70 mg/week, 42 with Risedronate, 35 mg/week, and 29 with Raloxifene, 60 mg/day), however, all of them were NR to this therapy. According to recent data, ability to improve patients’ QoL, which is the first objective to be such as the ICARO and OSSO studies (Adami et al., 2006; Cooper et al., 2007)NR pursued from a geriatric perspective. patients represent 10–25% of all SO patients. The mean SDI of our patients was In many previous studies (Lips and Van Schoor, 2005; Brenne- 5.92 Æ 1.27, their mean vertebral T-Score was À3.15 Æ 0.39, their main femoral T- man et al., 2006; Marcinkowska et al., 2006; Gold and Silverman, Score was À2.50 Æ 0.38. 2007; Marquis et al., 2007; Salaffi et al., 2007; Silverman et al., All these patients received for 18 months 20 mg/day of teriparatide in form of subcutaneous injections, and were taking also a supplementation of 1 g/day 2007) having used various drugs available for the treatment of calcium and 800 IU of vitamin D3; then for other 6 months they received only the osteoporosis, such as Alendronate, Risedronate, Oestrogen, Ralox- same amounts of calcium and vitamin D3. ifene and Strontium Ranelate, aspects concerning the reduction of The patients included in this study underwent a BMD analysis (DEXA-Lunar- back pain and overall pain, the consequent consumption of NSAID, DPX-P) on their lumbar vertebral column, and on their femur at start of the treatment (T ), as well as after 12, 18 and 24 months, respectively (T , T , and T ).