Tags

Type your tag names separated by a space and hit enter

Vertebral fracture risk after once-weekly teriparatide injections: follow-up study of Teriparatide Once-Weekly Efficacy Research (TOWER) trial.
Curr Med Res Opin. 2013 Mar; 29(3):195-203.CM

Abstract

OBJECTIVE

To evaluate fracture risk and bone mineral density (BMD) in patients with primary osteoporosis, 1 year after completing 72 weeks of weekly teriparatide injections.

RESEARCH DESIGN AND METHODS

After 72 weeks of teriparatide injections or placebo (original trial), treatment was unblinded and subjects were subsequently treated with bisphosphonates or other therapeutic regimens at the discretion of their physicians and followed for 1 year. Spine radiographs and BMD measurements at the lumbar spine, femoral neck, and total hip by dual energy X-ray absorptiometry were performed.

MAIN OUTCOME MEASURE

Incident vertebral fracture rate.

RESULTS

A total of 465 patients were enrolled and 447 (96.1%) completed the study. In the 1 year follow-up period, new morphometric vertebral fractures occurred in 7/203 (3.4%) in the post-teriparatide group and 33/241 (13.7%) in the post-placebo group (relative risk [RR]: 0.23, 95% confidence interval [CI]: 0.10 to 0.52, P < 0.05). The cumulative incidences from the start of the original trial were 4.9% and 22.8%, respectively (RR: 0.18, 95% CI: 0.09 to 0.36, P < 0.05). There were no significant differences in incidences of vertebral fractures between subsequent therapeutic regimens in the post-teriparatide group. In subjects treated with bisphosphonates, mean BMD values further significantly increased by 9.6%, 2.9%, and 4.1% at the lumbar spine, femoral neck, and total hip, respectively (P < 0.05).

CONCLUSIONS

The reduced risk of vertebral fracture was sustained for 1 year after completion of 72 weeks of weekly teriparatide injections. The effects did not differ between subsequent therapeutic regimens. BMD gains continued with sequential bisphosphonate treatment, but not with the other sequential therapeutic regimens. Bisphosphonates seem to be a useful choice as a subsequent treatment to weekly teriparatide.

LIMITATION

This study was an observational follow-up study and the regimens of subsequent medication after discontinuation of the original TOWER trial were not randomly allocated.

Authors+Show Affiliations

Internal Medicine 1, Shimane University Faculty of Medicine, Izumo, Shimane, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23259702

Citation

Sugimoto, Toshitsugu, et al. "Vertebral Fracture Risk After Once-weekly Teriparatide Injections: Follow-up Study of Teriparatide Once-Weekly Efficacy Research (TOWER) Trial." Current Medical Research and Opinion, vol. 29, no. 3, 2013, pp. 195-203.
Sugimoto T, Shiraki M, Nakano T, et al. Vertebral fracture risk after once-weekly teriparatide injections: follow-up study of Teriparatide Once-Weekly Efficacy Research (TOWER) trial. Curr Med Res Opin. 2013;29(3):195-203.
Sugimoto, T., Shiraki, M., Nakano, T., Kishimoto, H., Ito, M., Fukunaga, M., Hagino, H., Sone, T., Kuroda, T., & Nakamura, T. (2013). Vertebral fracture risk after once-weekly teriparatide injections: follow-up study of Teriparatide Once-Weekly Efficacy Research (TOWER) trial. Current Medical Research and Opinion, 29(3), 195-203. https://doi.org/10.1185/03007995.2012.761956
Sugimoto T, et al. Vertebral Fracture Risk After Once-weekly Teriparatide Injections: Follow-up Study of Teriparatide Once-Weekly Efficacy Research (TOWER) Trial. Curr Med Res Opin. 2013;29(3):195-203. PubMed PMID: 23259702.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vertebral fracture risk after once-weekly teriparatide injections: follow-up study of Teriparatide Once-Weekly Efficacy Research (TOWER) trial. AU - Sugimoto,Toshitsugu, AU - Shiraki,Masataka, AU - Nakano,Tetsuo, AU - Kishimoto,Hideaki, AU - Ito,Masako, AU - Fukunaga,Masao, AU - Hagino,Hiroshi, AU - Sone,Teruki, AU - Kuroda,Tatsuhiko, AU - Nakamura,Toshitaka, Y1 - 2013/01/17/ PY - 2012/12/25/entrez PY - 2012/12/25/pubmed PY - 2013/8/10/medline SP - 195 EP - 203 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 29 IS - 3 N2 - OBJECTIVE: To evaluate fracture risk and bone mineral density (BMD) in patients with primary osteoporosis, 1 year after completing 72 weeks of weekly teriparatide injections. RESEARCH DESIGN AND METHODS: After 72 weeks of teriparatide injections or placebo (original trial), treatment was unblinded and subjects were subsequently treated with bisphosphonates or other therapeutic regimens at the discretion of their physicians and followed for 1 year. Spine radiographs and BMD measurements at the lumbar spine, femoral neck, and total hip by dual energy X-ray absorptiometry were performed. MAIN OUTCOME MEASURE: Incident vertebral fracture rate. RESULTS: A total of 465 patients were enrolled and 447 (96.1%) completed the study. In the 1 year follow-up period, new morphometric vertebral fractures occurred in 7/203 (3.4%) in the post-teriparatide group and 33/241 (13.7%) in the post-placebo group (relative risk [RR]: 0.23, 95% confidence interval [CI]: 0.10 to 0.52, P < 0.05). The cumulative incidences from the start of the original trial were 4.9% and 22.8%, respectively (RR: 0.18, 95% CI: 0.09 to 0.36, P < 0.05). There were no significant differences in incidences of vertebral fractures between subsequent therapeutic regimens in the post-teriparatide group. In subjects treated with bisphosphonates, mean BMD values further significantly increased by 9.6%, 2.9%, and 4.1% at the lumbar spine, femoral neck, and total hip, respectively (P < 0.05). CONCLUSIONS: The reduced risk of vertebral fracture was sustained for 1 year after completion of 72 weeks of weekly teriparatide injections. The effects did not differ between subsequent therapeutic regimens. BMD gains continued with sequential bisphosphonate treatment, but not with the other sequential therapeutic regimens. Bisphosphonates seem to be a useful choice as a subsequent treatment to weekly teriparatide. LIMITATION: This study was an observational follow-up study and the regimens of subsequent medication after discontinuation of the original TOWER trial were not randomly allocated. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/23259702/Vertebral_fracture_risk_after_once_weekly_teriparatide_injections:_follow_up_study_of_Teriparatide_Once_Weekly_Efficacy_Research__TOWER__trial_ L2 - https://www.tandfonline.com/doi/full/10.1185/03007995.2012.761956 DB - PRIME DP - Unbound Medicine ER -