• Something wrong with this record ?

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

P. Aspenberg, J. Malouf, U. Tarantino, PA. García-Hernández, C. Corradini, S. Overgaard, JJ. Stepan, L. Borris, E. Lespessailles, F. Frihagen, K. Papavasiliou, H. Petto, JR. Caeiro, F. Marin,

. 2016 ; 98 (22) : 1868-1878.

Language English Country United States

Document type Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc17023494

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.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc17023494
003      
CZ-PrNML
005      
20170906124233.0
007      
ta
008      
170720s2016 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.2106/JBJS.15.01217 $2 doi
035    __
$a (PubMed)27852903
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Aspenberg, Per $u Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden per.aspenberg@liu.se. $7 gn_A_00009487
245    10
$a 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 / $c P. Aspenberg, J. Malouf, U. Tarantino, PA. García-Hernández, C. Corradini, S. Overgaard, JJ. Stepan, L. Borris, E. Lespessailles, F. Frihagen, K. Papavasiliou, H. Petto, JR. Caeiro, F. Marin,
520    9_
$a 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.
650    _2
$a senioři $7 D000368
650    _2
$a senioři nad 80 let $7 D000369
650    _2
$a kostní denzita $x účinky léků $7 D015519
650    _2
$a inhibitory kostní resorpce $x farmakologie $x terapeutické užití $7 D050071
650    _2
$a dvojitá slepá metoda $7 D004311
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a hojení fraktur $x účinky léků $7 D017102
650    _2
$a fraktury kyčle $x farmakoterapie $7 D006620
650    _2
$a lidé $7 D006801
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a kyselina risedronová $x farmakologie $x terapeutické užití $7 D000068296
650    _2
$a teriparatid $x farmakologie $x terapeutické užití $7 D019379
650    _2
$a výsledek terapie $7 D016896
655    _2
$a srovnávací studie $7 D003160
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a Malouf, Jorge $u Internal Medicine, Hospital San Pablo, Barcelona, Spain jmalouf@santpau.cat.
700    1_
$a Tarantino, Umberto $u Orthopaedic Surgery, University Tor Vergata, Rome, Italy umberto.tarantino@uniroma2.it.
700    1_
$a García-Hernández, Pedro A $u Osteoporosis Center, University Hospital, Monterrey, Mexico pedroalbertogh@yahoo.com.
700    1_
$a Corradini, Costantino $u Department of Biomedical Surgical and Dental Sciences, University of Milan, c/o I Division of Orthopaedics and Traumatology, A.O. Orthopaedic Institute, Milan, Italy costantino.corradini@unimi.it.
700    1_
$a Overgaard, Søren $u Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark soeren.overgaard@rsyd.dk. Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
700    1_
$a Stepan, Jan J $u Institute of Rheumatology and Faculty of Medicine 1, Charles University, Prague, Czech Republic stepan@revma.cz.
700    1_
$a Borris, Lars $u Orthopaedic Surgery, University Hospital, Aarhus, Denmark larsborr@rm.dk.
700    1_
$a Lespessailles, Eric $u IPROS, Department of Rheumatology, C.H.R Orléans, Orléans, France eric.lespessailles@chr-orleans.fr. I3MTO, Orléans University, Orléans, France.
700    1_
$a Frihagen, Frede $u Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway ffrihagen@gmail.com.
700    1_
$a Papavasiliou, Kyriakos $u 3rd Orthopaedic Department, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece kyrpap2005@yahoo.com.
700    1_
$a Petto, Helmut $u Eli Lilly, Vienna, Austria petto_helmut@lilly.com.
700    1_
$a Caeiro, José Ramón $u Department of Orthopaedic Surgery and Traumatology, Santiago de Compostela University Hospital, Health Research Institute, University of Santiago de Compostela, Santiago de Compostela, Spain jrcaeiro@telefonica.net.
700    1_
$a Marin, Fernando $u Eli Lilly Research Centre, Windlesham, United Kingdom marin_fernando@lilly.com.
773    0_
$w MED00002557 $t The Journal of bone and joint surgery. American volume $x 1535-1386 $g Roč. 98, č. 22 (2016), s. 1868-1878
856    41
$u https://pubmed.ncbi.nlm.nih.gov/27852903 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20170720 $b ABA008
991    __
$a 20170906124831 $b ABA008
999    __
$a ok $b bmc $g 1239175 $s 984407
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2016 $b 98 $c 22 $d 1868-1878 $i 1535-1386 $m Journal of bone and joint surgery. American volume $n J Bone Joint Surg Am $x MED00002557
LZP    __
$a Pubmed-20170720

Find record

Citation metrics

Archiving options