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SummaryPioglitazone use is associated with an increased risk of fractures. In this randomized, placebo-controlled study, pioglitazone use for 12 months was associated with a significant increase in bone marrow fat content at the femoral neck, accompanied by a significant decrease in total hip bone mineral density. The change in bone marrow fat with pioglitazone use was predominantly observed in female vs. male participants.IntroductionUse of the insulin sensitizer pioglitazone is associated with greater fracture incidence, although the underlying mechanisms are incompletely understood. This study aimed to assess the effect of pioglitazone treatment on femoral neck bone marrow (BM) fat content and on bone mineral density (BMD), and to establish if any correlation exists between the changes in these parameters.MethodsIn this double-blind placebo-controlled clinical trial, 42 obese volunteers with metabolic syndrome were randomized to pioglitazone (45 mg/day) or matching placebo for 1 year. The following measurements were conducted at baseline and during the treatment: liver, pancreas, and femoral neck BM fat content (by magnetic resonance spectroscopy), BMD by DXA, abdominal subcutaneous and visceral fat, and beta-cell function and insulin sensitivity.ResultsResults were available for 37 subjects who completed the baseline and 1-year evaluations. At 12 months, BM fat increased with pioglitazone (absolute change, +4.1%, p = 0.03), whereas BM fat content in the placebo group decreased non-significantly (−3.1%, p = 0.08) (p = 0.007 for the pioglitazone–placebo response difference). Total hip BMD declined in the pioglitazone group (−1.4%) and increased by 0.8% in the placebo group (p = 0.03 between groups). The change in total hip BMD was inversely and significantly correlated with the change in BM fat content (Spearman rho = −0.56, p = 0.01) in the pioglitazone group, but not within the placebo group (rho = −0.29, p = 0.24). Changes in BM fat with pioglitazone were predominantly observed in female vs. male subjects.ConclusionsPioglitazone use for 12 months compared with placebo is associated with significant increase in BM fat content at the femoral neck, accompanied by a small but significant decrease in total hip BMD.

Summary Once-weekly administration of 56.5 μg teriparatide improved cortical bone parameters and biomechanical parameters at the proximal femur by CT geometry analysis. Introduction The aim of this study was to evaluate the effects of weekly administration of teriparatide [human PTH (1–34)] on bone geometry, volumetric bone mineral density (vBMD), and parameters of bone strength at the proximal femur which were longitudinally investigated using computed tomography (CT). Methods The subjects were a subgroup of a recent, randomly assigned, double-blind study (578 subjects) comparing the anti-fracture efficacy of a once-weekly subcutaneous injection of 56.5 μg teriparatide with placebo (TOWER trial). Results Sixty-six ambulatory postmenopausal women with osteoporosis were enrolled at 15 study sites having multi-detector row CT, and included women injected with teriparatide ( n  = 29, 74.2 ± 5.1 years) or with placebo ( n  = 37, 74.8 ± 5.3 years). CT data were obtained at baseline and follow-up scans were performed at 48 and 72 weeks. The data were analyzed to obtain cross-sectional densitometric, geometric, and biomechanical parameters including the section modulus (SM) and buckling ratio (BR) of the femoral neck, inter-trochanter, and femoral shaft. We found that once-weekly teriparatide increased cortical thickness/cross-sectional area (CSA) and total area, and improved biomechanical properties (i.e., decreasing BR) at the femoral neck and shaft. Teriparatide did not change the cortical perimeter. Conclusions Our longitudinal analysis of proximal femur geometry by CT revealed that once-weekly administration of 56.5 μg teriparatide improved cortical bone parameters at the femoral neck and shaft and also improved biomechanical parameters.

Theoretically, concomitant therapy with parathyroid hormone and alendronate might be synergistic, increasing bone formation while simultaneously reducing resorption. In this study, 238 postmenopausal women with osteoporosis were randomly assigned to receive daily parathyroid hormone (1–84), alendronate, or both for 12 months. Bone mineral density increased in all groups, with no significant differences between those receiving parathyroid hormone and those receiving both drugs. Bone formation increased markedly with parathyroid hormone therapy but not with combined therapy. No evidence of synergy with PTH plus alendronate. The prevention of osteoporotic fractures with the use of antiresorptive drugs represents an established therapeutic approach for patients with osteoporosis. 1 – 3 The results of double-blind, randomized, placebo-controlled trials have indicated that nitrogen-containing bisphosphonates such as alendronate and risedronate, which work principally by suppressing bone resorption, reduce the risk of fracture and increase bone mineral density. 4 – 8 Unlike bisphosphonates, parathyroid hormone is anabolic when it is administered intermittently for osteoporosis. Both parathyroid hormone (1–34) and parathyroid hormone (1–84) increase bone density by stimulating bone formation rather than by reducing bone resorption. 9 – 12 Recently, the 34-amino-acid fragment, parathyroid hormone (1–34), was shown . . .

Parathyroid hormone increases both bone formation and bone resorption, and combining it with an antiresorptive agent might enhance its effects on bone mineral density. Eighty-three men, 46 to 85 years of age, with low bone mineral density were randomly assigned to receive alendronate, parathyroid hormone, or both; alendronate therapy was given for 30 months, and parathyroid hormone therapy was begun at month 6. Bone mineral density at the lumbar spine and the femoral neck increased significantly more with parathyroid hormone alone than with alendronate alone or combination therapy. Alendronate may attenuate PTH-induced bone formation. Osteoporosis affects more than 20 million people in the United States and leads to about 1.5 million fractures in this country each year. 1 Although osteoporotic fractures are more common in women, about 30 percent of such fractures occur in men. 2 Alendronate, a potent nitrogen-containing bisphosphonate, inhibits osteoclastic bone resorption. 3 Alendronate increases bone mineral density and reduces the risk of fracture in women 4 – 6 and men 7 , 8 with osteoporosis. Once-daily administration of a parathyroid hormone fragment also increases bone mineral density in men with osteoporosis 9 , 10 and in estrogen-deficient women 11 – 13 and reduces the risk of fracture in postmenopausal women with . . .

Acute spinal cord injury is associated with rapid bone loss and an increased risk of fracture. In this double-blind, randomized, placebo-controlled trial, 17 patients were followed for 1 year after administration of either 4 or 5 mg of zoledronic acid or placebo. Bone mineral density (BMD) and structural analyses of the proximal femur were performed using the hip structural analysis program at entry, 6 months, and 12 months. The 17 subjects completed 12 months of observation, nine receiving placebo and eight zoledronic acid. The placebo group showed a decrease in BMD, cross-sectional area, and section modulus and an increase in buckling ratio at each proximal femur site at 6 and 12 months. Six months after zoledronic acid, BMD, cross-sectional area, and section modulus increased at the femoral neck and intertrochanteric regions and buckling ratio decreased consistent with improved bone stability. However, at 12 months, the femoral narrow-neck values declined to baseline. In contrast to placebo, the intertrochanteric region and femur shaft were maintained at or near baseline through 12 months in the zoledronic acid-treated group. Urine N-telopeptide excretion was increased at baseline and declined in both the placebo and treatment groups during the 12 months of observation. We conclude that a single administration of zoledronic acid will ameliorate bone loss and maintain parameters of bone strength at the three proximal femur sites for 6 months and at the femur intertrochanteric and shaft sites for 12 months.

Summary Hip structural analysis (HSA) performed in a subset of participants from the STudy Researching Osteoporosis iN Guys (STRONG) demonstrated that 1 year of ibandronate treatment was associated with a significant improvement in some but not all parameters of hip geometry relative to placebo in men with low bone density. Introduction HSA was performed on dual-energy X-ray absorptiometry (DXA) images in a subset of participants from the STRONG to examine the impact of monthly ibandronate on geometric properties of the hip in men with low bone density. Methods This prespecified subgroup analysis evaluated men in the intent-to-treat population of STRONG with baseline and 12-month DXA data. Cross-sectional geometric parameters of the femoral shaft (FS), intertrochanter region (IT), and narrow neck (NN) were calculated from femoral DXA scans. All analyses were exploratory. Treatment differences were evaluated using analysis of covariance, which adjusted for baseline parameter value, testosterone level, and treatment. Results HSA was performed on DXA scans from 89 men (34 placebo; 55 monthly ibandronate). Significant increases in average cortical thickness and cross-sectional area and decreases (i.e., improvements) in the buckling ratio were observed at the FS and IT at 12 months for ibandronate-treated men compared with placebo-treated men. No significant differences were observed between ibandronate and placebo for any NN HSA parameters. Conclusions One year of ibandronate treatment was associated with a significant improvement in some but not all parameters of hip geometry relative to placebo in men with low bone density, suggesting that ibandronate may improve resistance to axial compressive forces and bending forces at the hip.

Objective: This study aimed to investigate the effect of anti-osteoporosis therapy on plasma aldosterone concentration (PAC), plasma renin concentration (PRC) and the aldosterone/renin ratio (ARR) in patients with postmenopausal osteoporosis. Methods: In 60 patients with postmenopausal osteoporosis, bone mineral density (BMD), PAC and PRC were measured before and after treatment with alendronate (70 mg/week, n=22) or recombinant human parathyroid hormone (20 μg/day, n=35) for 48 weeks. Results: PAC was negatively correlated with the T-score of lumbar spine BMD and femoral neck BMD (lumbar r=−0.386, p<0.01; femoral neck r=−0.262, p<0.05). With the improvement in lumbar BMD after anti-osteoporosis treatment (T-score −3.4±0.5 vs. –3.1 ±0.4, p<0.0001), PAC decreased from 182.8±53.2 to 143.7±68.6 pg/mL (p<0.0001), PRC increased from 7.8±11.6 to 39.2±50.0 μIU/mL (p<0.0001) and the ARR decreased from 74.8±75.2 to 13.1±17.1 pg/μIU (p<0.0001). At baseline, 58% (35/60) of the patients had an ARR >37 pg/μIU, and the proportion decreased to 8% (5/57) after treatment. Conclusion: Treatment with alendronate or parathyroid hormone causes decreased PAC and increased PRC, resulting in a decreased ARR in postmenopausal women with osteoporosis.

Background Hip replacement (arthroplasty) surgery is a highly successful treatment for patients with severe symptomatic arthritis of the hip joint. For older patients, several designs of Total Hip Arthroplasty have shown excellent results in terms of both function and value for money. However, in younger more active patients, there is approximately a 50% failure rate at 25 years for traditional implants. Hip resurfacing is a relatively new arthroplasty technique. In a recent review of the literature on resurfacing arthroplasty it was concluded that the short-term functional results appear promising but some potential early disadvantages were identified, including the risk of femoral neck fracture and collapse of the head of the femur.The aim of the current study is to assess whether there is a difference in functional hip scores at one year post-operation between Total Hip Arthroplasty and Resurfacing Arthroplasty. Secondary aims include assessment of complication rates for both procedures as well cost effectiveness. Methods/design All patients medically fit for surgery and deemed suitable for a resurfacing arthroplasty are eligible to take part in this study. A randomisation sequence will be produced and administered independently. After consenting, all patients will be clinically reviewed and hip function, quality of life and physical activity level will be assessed through questionnaires. The allocated surgery will then be performed with the preferred technique of the surgeon. Six weeks post-operation hip function will be assessed and complications recorded. Three, six and 12 months post-operation hip function, quality of life and physical activity level will be assessed. Additional information about patients' out-of-pocket expenses will also be collected. Trial registration Current Controlled Trials ISRCTN33354155 UKCLRN portfolio ID 4093

IntroductionCam morphology is a strong risk factor for the development of hip pain and osteoarthritis. It is increasingly thought to develop in association with intense physical activity during youth; however, the aetiology remains uncertain. The study aim was to characterise the effect of physical activity on morphological hip development during adolescence.MethodsCross-sectional study of individuals aged 9–18 years recruited from Southampton Football Club Academy (103 male) with an age-matched control population (52 males and 55 females). Assessments included questionnaires and 3 Tesla MRI of both hips. Alpha angle, epiphyseal extension and epiphyseal tilt were measured on radial images.ResultsAlpha angle and epiphyseal extension increased most rapidly between ages 12 and 14 years. Soft-tissue hypertrophy at the femoral head-neck junction preceded osseous cam morphology and was first evident at age 10 years. The greatest increase and highest absolute values of alpha angle and epiphyseal extension were colocalised at 1 o’clock. Maximum alpha angles were 6.7 degrees greater in males than females (p=0.005). Compared with individuals who play no regular sport, alpha angles were 4.0 degrees higher in individuals who play sport for a school or club (p=0.041) and 7.7 degrees higher in individuals competing at a national or international level (p=0.035). There was no association with leg dominance .ConclusionsSporting activity during adolescence is strongly associated with the development of cam morphology secondary to epiphyseal hypertrophy and extension with a dose-response relationship. Males participating in competitive sport are at particularly elevated risk of developing cam morphology and secondary hip pathology.

Very rapid bone loss, osteopenia and skeletal morbidity after renal transplantation have been well documented and found to occur in a sex dependent fashion. Glucocorticoids, cyclosporine and pre-existing uremic osteodystrophy have been implicated in the pathogenesis of the skeletal lesions. Glucocorticoid induced osteopenia is also a serious clinical problem in patients with various nonrenal diseases and can be prevented, or at least attenuated, by pamidronate and other bisphosphonates. We prospectively studied 26 male patients undergoing renal transplantation, and randomized them to receive either placebo or intravenous pamidronate (0.5 mg/kg) at the time of transplantation and again one month later. All patients received immunosuppression comprising prednisolone, cyclosporine and azathioprine. The bone mineral density (BMD) of the second, third and fourth lumbar vertebrae and of the femoral neck was measured at the time of transplantation and at three months and 12 months after transplantation using dual energy X-ray absorptiometry (DXA). Twelve months after transplantation, the mean (+/- SEM) BMD of the lumbar vertebrae in patients who received placebo had decreased 6.4% (P < 0.05). In contrast, patients who received pamidronate experienced no significant reduction of BMD at the lumbar vertebrae. At the femoral neck, placebo-treated patients showed a reduction of BMD of 9% (P < 0.005), whereas there was no significant change in the pamidronate treated group. The two study groups had similar patient profiles, serum parathyroid hormone (PTH) and aluminium concentrations. After transplantation, comparable falls in the serum creatinine and PTH concentration were found in the two groups. Apart from transient hypocalcemia in two patients, no significant adverse effects of pamidronate were noted. This study has shown that the early rapid bone loss that occurs in men during the first 12 months after renal transplantation can be prevented by two intravenous doses of pamidronate given at transplantation and one month later. The regimen was simple to administer, well tolerated and potentially applicable to other clinical groups of glucocorticoid treatment patients.