Mounting evidence implicates bariatric surgery as a cause of increased skeletal fragility and fracture risk. Bisphosphonate therapy reduces osteoporotic fracture risk and may be effective in minimizing bone loss associated with bariatric surgery. The main objective of this pilot randomized controlled trial (RCT; Clinical Trial No. NCT03411902) was to determine the feasibility of recruiting, treating, and following 24 older patients who had undergone sleeve gastrectomy in a 6 month RCT examining the efficacy of 150-mg once-monthly risedronate (versus placebo) in the prevention of surgical weight-loss-associated bone loss. Feasibility was defined as: (i) >30% recruitment yield, (ii) >80% retention, (iii) >80% pills taken, (iv) <20% adverse events (AEs), and (v) >80% participant satisfaction. Study recruitment occurred over 17 months. Seventy participants were referred, with 24 randomized (34% yield) to risedronate (n = 11) or placebo (n = 13). Average age was 56 AE 7 years, 83% were female (63% postmenopausal), and 21% were black. The risedronate group had a higher baseline BMI than the placebo group (48.1 AE 7.2 versus 41.9 AE 3.8 kg/m 2). The 10-year fracture risk was low (6.0% major osteoporotic fracture, 0.4% hip fracture); however, three individuals (12.5%, all risedronate group) were osteopenic at baseline. Twenty-one participants returned for 6-month follow-up testing (88% retention) with all (n = 3) loss to follow-up occurring in the risedronate group. Average number of pills taken among completers was 5.9 AE 0.4 and 6.0 AE 0.0 in the risedronate and placebo groups, respectively (p = 0.21), with active participants taking >80% of allotted pills. Five AEs (3.7% AE rate) were reported; one definitely related, four not related, and none serious. All participants reported high satisfaction with participation in the study. Use of bisphosphonates as a novel therapeutic to preserve bone density in patients who had undergone a sleeve gastrectomy appears feasible and well-tolerated. Knowledge gained from this pilot RCT will be used to inform the design of an appropriately powered trial.
Despite well recognized improvements in obesity-related comorbidities, increasing evidence implicates bariatric surgery in the onset of adverse skeletal health outcomes. The purpose of this review is to provide a focused update in three critical areas: 1) emergent data on sleeve gastrectomy and bone loss, 2) evidence linking bariatric surgery to incident fracture, and 3) intervention strategies designed to mitigate surgical bone loss. Better understanding of these issues will inform our treatment of skeletal health for patients planning bariatric surgery.
The effects of long-duration spaceflight on crewmember neck musculature have not been adequately studied. The purpose of this study was to evaluate the changes in the neck musculature on pre-flight and post-flight magnetic resonance imaging (MRI) examinations of six crewmembers on 4- to 6-month missions equipped with the advanced resistive exercise device (aRED). The MRI images were resliced to remove variations in spinal curvature, the cross-sectional area (CSA), and muscle fat infiltration (MFI) of neck musculature at the C1-C2, C4-C5, C7-T1, and T1-T2 intervertebral disc levels were measured bilaterally. Percent changes in the neck muscle CSA and fatty infiltration following spaceflight were calculated, and mixed models were used to assess significance of these changes. Crewmembers on missions equipped with the aRED experienced an average 25.1% increase in CSA for the trapezius muscle at C6-C7, an average 11.5% increase in CSA for the semispinalis capitis muscle at C4-C5, an average 9.0% increase in CSA for the sternocleidomastoid muscle at C4-C5, and an average 23.1% increase in CSA for the rhomboid minor at T1-T2. There were no significant changes in the CSA of the levator scapulae, splenius capitis, rectus capitis posterior major, scalenus anterior, scalenus posterior, scalenus medius, longissimus capitis, or obliquus capitis inferior muscles at the locations measured. None of the muscles analyzed experienced statistically significant changes in fatty infiltration with spaceflight. Our study indicates that long-duration spaceflight conditions are associated with preservation of CSA in most neck muscles and significant increases in the CSAs of the trapezius, semispinalis capitis, sternocleidomastoid, and rhomboid minor muscles. This may indicate that cervical muscles are not subjected to the same degradative effects microgravity imparts on the majority of muscles.
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