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Effects of Teriparatide Compared with Risedronate on Recovery After Pertrochanteric Hip Fracture Results of a Randomized, Active-Controlled, Double-Blind Clinical Trial at 26 Weeks
- Source :
- JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, instname, Europe PubMed Central, Aspenberg, P, Malouf, J, Tarantino, U, García-Hernández, P A, Corradini, C, Overgaard, S, Stepan, J J, Borris, L, Lespessailles, E, Frihagen, F, Papavasiliou, K, Petto, H, Caeiro, J R & Marin, F 2016, ' Effects of Teriparatide Compared with Risedronate on Recovery After Pertrochanteric Hip Fracture : Results of a Randomized, Active-Controlled, Double-Blind Clinical Trial at 26 Weeks ', Journal of Bone and Joint Surgery: American Volume, vol. 98, no. 22, pp. 1868-1878 . https://doi.org/10.2106/JBJS.15.01217
- Publication Year :
- 2016
- Publisher :
- LIPPINCOTT WILLIAMS & WILKINS, 2016.
-
Abstract
- BACKGROUND: Osteoporosis drugs might affect fracture-healing. We therefore studied the effects of teriparatide in comparison with risedronate on recovery after pertrochanteric hip fractures.METHODS: The study was a randomized, multicenter, active-controlled, 78-week trial comparing teriparatide (20 μg/day) with risedronate (35 mg/week) initiated within 2 weeks after fixation of a low-trauma pertrochanteric hip fracture (AO/OTA 31-A1 or 31-A2). The main inclusion criteria were a bone mineral density T-score of ≤-2.0 and 25-OH-vitamin D of ≥9.2 ng/mL. During the first 26 weeks, patients received study medication with oral or injectable placebo plus calcium and vitamin D in a double-blinded fashion. Secondary (Timed Up-and-Go [TUG] test, hip pain, Short Form [SF]-36 health status, and safety) and exploratory (radiographic outcomes and ability to walk) 26-week end points are reported.RESULTS: Of the 224 patients who were randomized, 171 (86 teriparatide, 85 risedronate) were included in the analysis. The mean age was 77 ± 8 years, 77% were female, and 26% had a prior history of low-trauma fracture. The teriparatide group completed the TUG test in a shorter time at 6, 12, 18, and 26 weeks (differences of -5.7, -4.4, -3.1, and -3.1 seconds, respectively; p = 0.021 for the overall difference). They also reported less pain on a visual analog scale immediately after the TUG test at 12 and 18 weeks (adjusted absolute differences of 10.6 and 11.9 mm, respectively; p < 0.05). There were no significant between-group differences in the SF-36 score, Charnley hip pain score, ability to walk, or use of walking aids during follow-up. Radiographic healing at 6, 12, and 26 weeks, mechanical failure of the implant (teriparatide, 7; risedronate, 8), loss of reduction (teriparatide, 2; risedronate, 4), and nonunion (0 cases) were not significantly different. Mild hypercalcemia and hyperuricemia were more frequent with teriparatide.CONCLUSIONS: Teriparatide was associated with less pain and a shorter time to complete the TUG test between 6 and 26 weeks compared with risedronate. Other fracture-recovery outcomes were similar. The results should be interpreted with caution as these were secondary end points.LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
- Subjects :
- Male
medicine.medical_specialty
Scientific Articles
Visual analogue scale
Osteoporosis
Nonunion
030209 endocrinology & metabolism
Placebo
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Double-Blind Method
law
Bone Density
Teriparatide
medicine
Settore MED/33 - Malattie Apparato Locomotore
Humans
Orthopedics and Sports Medicine
10. No inequality
Aged
Aged, 80 and over
Fracture Healing
030222 orthopedics
Hip fracture
Bone Density Conservation Agents
business.industry
Hip Fractures
General Medicine
medicine.disease
3. Good health
Surgery
Treatment Outcome
Orthopedic surgery
Female
business
Risedronic Acid
medicine.drug
Subjects
Details
- ISSN :
- 00219355
- Database :
- OpenAIRE
- Journal :
- JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, instname, Europe PubMed Central, Aspenberg, P, Malouf, J, Tarantino, U, García-Hernández, P A, Corradini, C, Overgaard, S, Stepan, J J, Borris, L, Lespessailles, E, Frihagen, F, Papavasiliou, K, Petto, H, Caeiro, J R & Marin, F 2016, ' Effects of Teriparatide Compared with Risedronate on Recovery After Pertrochanteric Hip Fracture : Results of a Randomized, Active-Controlled, Double-Blind Clinical Trial at 26 Weeks ', Journal of Bone and Joint Surgery: American Volume, vol. 98, no. 22, pp. 1868-1878 . https://doi.org/10.2106/JBJS.15.01217
- Accession number :
- edsair.doi.dedup.....54fd0dc7eac4c7858ce3a3581816c71c
- Full Text :
- https://doi.org/10.2106/JBJS.15.01217