PurposeIn women with postmenopausal osteoporosis, we investigated the effects of 24 months of treatment with alendronate (ALN) following 18 months of treatment with abaloparatide (ABL) or placebo (PBO).MethodsWomen who completed ABL or PBO treatment in ACTIVE were eligible to receive up to 24 months of ALN. We evaluated the incidence of vertebral and nonvertebral fractures and changes in bone mineral density (BMD) during the entire 43-month period from ACTIVE baseline to the end of ACTIVExtend and for the 24-month extension only.ResultsFive hundred fifty-eight women from ACTIVE’s ABL group and 581 from its PBO group (92% of ABL and PBO completers) were enrolled. During the full 43-month treatment period, 0.9% of evaluable women in the ABL/ALN group experienced a new radiographic vertebral fracture vs 5.6% of women in the PBO/ALN group, an 84% relative risk reduction (RRR, P < 0.001). Kaplan–Meier incidence rates for other reported fracture types were significantly lower for ABL/ALN vs PBO/ALN (all P < 0.05). Gains in BMD achieved during ACTIVE were further increased during ACTIVExtend. For ACTIVExtend only, RRR for vertebral fractures was 87% with ABL/ALN vs PBO/ALN (P = 0.001). Adverse events were similar between groups. A supplemental analysis for regulatory authorities found no hip fractures in the ABL/ALN group vs five in the PBO/ALN group.ConclusionsEighteen months of ABL followed by 24 months of ALN reduced the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and increased BMD. Sequential ABL followed by ALN appears to be an effective treatment option for postmenopausal women at risk for osteoporosis-related fractures.
Abaloparatide-SC is a novel 34-amino acid peptide created to be a potent and selective activator of the parathyroid hormone receptor type 1 (PTHR1) signaling pathway. In the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) Phase 3 trial (NCT01343004), abaloparatide reduced new morphometric vertebral fractures by 86% compared with placebo (p < 0.001) and nonvertebral fractures by 43% (p ¼ 0.049) in postmenopausal women with osteoporosis. Abaloparatide-SC increased bone mineral density (BMD) 3.4% at the total hip, 2.9% at the femoral neck, and 9.2% at the lumbar spine at 18 months (all p < 0.001 versus placebo). The analysis reported here was designed to evaluate whether fracture risk reductions and BMD accrual were consistent across different levels of baseline risk. Risk factor subgroups were predefined categorically for BMD T-score of the lumbar spine, total hip, and femoral neck ( -2.5 versus >-2.5 and -3.0 versus >-3.0), history of nonvertebral fracture (yes versus no), prevalent vertebral fracture (yes versus no), and age (<65 versus 65 to <75 versus !75 years) at baseline. Forest plots show that there were no clinically meaningful interactions between any of the baseline risk factors and the treatment effect of abaloparatide-SC on new morphometric vertebral fractures, nonvertebral fractures, or BMD increases. Abaloparatide provides protection against fractures consistently across a wide variety of ages and baseline risks, including those with and without prior fractures, and it has potential utility for a broad group of postmenopausal women with osteoporosis.
clinicaltrials.gov Identifier: NCT01657162.
The success of cervical cancer control programs depends on regular screening with the Pap smear test and prompt and appropriate treatment of early neoplastic lesions. Recognizing the potentially grave consequences of lack of follow-up for abnormal Pap smears, numerous intervention studies have tested the impact of a variety of strategies to increase return for follow-up. The majority of these studies were evaluated under controlled experimental conditions. Despite the encouraging findings of these trials, the next step in the research continuum requires that the effectiveness of these interventions be demonstrated in real world settings before full implementation is initiated. We report the results of an evaluation study assessing the combined effectiveness of three intervention modalities found effective in prior randomized studies: a tracking follow-up protocol, transportation incentives, and financial incentives. This study used a before-after, nonequivalent control group design to assess the impact of a multifaceted intervention that included a computerized tracking protocol with transportation and financial incentives. The study was implemented at two major hospitals, two comprehensive health centers (CHC), and nine public health centers (PHC) under the jurisdiction of the Los Angeles County Department of Health Services. One hospital, one CHC, and the four PHC located in the catchment area of the CHC were selected as experimental sites. The control sites - one hospital, one CHC, and five PHC - provided usual care. All women with an abnormal Pap smear at the intervention and control sites were included in the study. The study consisted of a 1-year period of baseline data collection (September 1989-August 1990), followed by a 2(1/2)-year intervention period (September 1990-February 1993). During the intervention period, the intervention protocol was implemented at the experimental sites, and the control sites provided usual care. Overall, we found that the rates of receipt of follow-up care were consistent with those found in similar studies. In contrast to results obtained in these prior randomized trials, we did not find strong and consistent evidence for intervention effects. Significant findings emerged only at the CHC and hospital levels and only for selected years. Results underscore the importance of testing interventions in real world conditions before large-scale implementation is initiated. In addition, this study highlights the challenge of detecting intervention effects in large-scale studies because of the greater measurement difficulties in field studies as compared with controlled experiments.
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