An already available drug can help patients get back on their feet more rapidly after a hip fracture, according to an international study.
The results suggest that treatment with the drug accelerates the healing process in broken bones. “We have shown that patients are more mobile and suffer less pain after a hip fracture when they receive this treatment,” says Dr Per Aspenberg, professor of orthopaedics at Linköping University in Sweden, and principal author of the study.
The drug tested by the researchers, teriparatide, is based on a naturally occurring hormone, parathyroid hormone (PTH). Teriparatide is the active ingredient in human PTH and is currently used to treat osteoporosis (brittle bones). The hormone influences bone structure.
“Bones contain both cells that break down bone and cells that create new bone. This hormone stimulates both types, but it has a greater effect on the cells that create new bone, and the skeleton is thus made stronger. Previous work by my research group in animals has shown that the beneficial effect of the hormone is much stronger during the healing of broken bones than it is for the skeleton in general, such as when it is used to treat osteoporosis,” says Aspenberg.
The study looked at 171 patients with a fracture in the transition between the neck of the femur and its body, known as a pertrochanteric fracture. The patients were assigned at random to one of two groups: those who received teriparatide after the surgery, and those who received another drug commonly used to treat osteoporosis. Neither the patients nor the personnel who administered the tests knew which treatment a particular patient received. The patients carried out a test in which they rose from a chair, walked three metres, turned round, walked back and sat down again. The investigators timed the patients as they carried out the test. Those who received teriparatide moved more rapidly than those in the other group in the months following the surgery. They also estimated the pain they experienced when carrying out the test to be lower.
“It’s my conclusion that this study shows clearly that treatment with PTH accelerates the healing process of fractures in such a manner that patients benefit from it. They are able to function better after six weeks and after three months. This is the first time that this has been shown in a scientifically convincing manner,” says Aspenberg.
The study has been carried out across 17 countries, and was conducted by a pharmaceuticals company with the participation of researchers from the company, hospitals and universities.
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 [mu]g/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.
Per Aspenberg, Jorge Malouf, Umberto Tarantino, Pedro A García-Hernández, Costantino Corradini, Søren Overgaard, Jan J Stepan, Lars Borris, Eric Lespessailles, Frede Frihagen, Kyriakos Papavasiliou, Helmut Petto, José Ramón Caeiro, Fernando Marin