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Effect of zoledronic acid on serum calcium in Paget's disease patients after educational strategies to improve calcium and vitamin D supplementation.

ABSTRACT: OBJECTIVE:Bisphosphonates are the most effective therapeutic agents in patients with Paget's disease of bone. As a result of their inhibition of osteoclastic activity, hypocalcemia of variable frequency and severity following intravenous bisphosphonate therapy has been reported. The present study assessed the effect of physician and patient education on adequate supplementation of calcium and vitamin D to reduce the potential risk of developing hypocalcemia following infusion of 5 mg zoledronic acid. METHODS:This was an open-label, multicenter, controlled registry trial in which patients with Paget's disease were treated with a single intravenous infusion of zoledronic acid. Physicians were provided with educational materials focusing on optimization of calcium and vitamin D supplementation following zoledronic infusion that they used to educate their patients. The primary safety variable was the percentage of patients with serum calcium level <2.07mmol/l 9-11 days after zoledronic acid infusion. RESULTS:A total of 75 patients were evaluable in the post dose hypocalcemia safety analysis. Of these, only 1 patient had treatment-emergent hypocalcemia, with a serum calcium level of 1.92 mmol/l 4 days following therapy. Hypocalcemia-related symptoms were not reported in this patient and the serum calcium returned to normal range at 2.17 mmol/l within 1 week on oral calcium supplementation. CONCLUSIONS:These results suggest that, with optimization of calcium and vitamin D supplementation by physician and patient education, hypocalcemia is an infrequent occurrence following zoledronic acid infusion.

SUBMITTER: Tucci JR

PROVIDER: S-EPMC4525125 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Effect of zoledronic acid on serum calcium in Paget's disease patients after educational strategies to improve calcium and vitamin D supplementation.

Tucci Joseph R JR Bone Henry G HG Su Guoqin G Tan Monique M Ozturk Zafer E ZE Aftring Paul P

Therapeutic advances in endocrinology and metabolism 20150801 4

<h4>Objective</h4>Bisphosphonates are the most effective therapeutic agents in patients with Paget's disease of bone. As a result of their inhibition of osteoclastic activity, hypocalcemia of variable frequency and severity following intravenous bisphosphonate therapy has been reported. The present study assessed the effect of physician and patient education on adequate supplementation of calcium and vitamin D to reduce the potential risk of developing hypocalcemia following infusion of 5 mg zol ...[more]

PMID: 26301065

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Project description:IntroductionPaget's disease of bone (PDB) is characterised by increased and disorganised bone remodelling affecting one or more skeletal sites. Complications include bone pain, deformity, deafness and pathological fractures. Mutations in sequestosome-1 (SQSTM1) are strongly associated with the development of PDB. Bisphosphonate therapy can improve bone pain in PDB, but there is no evidence that treatment alters the natural history of PDB or prevents complications. The Zoledronate in the Prevention of Paget's disease trial (ZiPP) will determine if prophylactic therapy with the bisphosphonate zoledronic acid (ZA) can delay or prevent the development of PDB in people who carry SQSTM1 mutations.Methods and analysisPeople with a family history of PDB aged >30 years who test positive for SQSTM1 mutations are eligible to take part. At the baseline visit, participants will be screened for the presence of bone lesions by radionuclide bone scan. Biochemical markers of bone turnover will be measured and questionnaires completed to assess pain, health-related quality of life (HRQoL), anxiety and depression. Participants will be randomised to receive a single intravenous infusion of 5 mg ZA or placebo and followed up annually for between 4 and 8 years at which point baseline assessments will be repeated. The primary endpoint will be new bone lesions assessed by radionuclide bone scan. Secondary endpoints will include changes in biochemical markers of bone turnover, pain, HRQoL, anxiety, depression and PDB-related skeletal events.Ethics and disseminationThe study was approved by the Fife and Forth Valley Research Ethics Committee on 22 December 2008 (08/S0501/84). Following completion of the trial, a manuscript will be submitted to a peer-reviewed journal. The results of this trial will inform clinical practice by determining if early intervention with ZA in presymptomatic individuals with SQSTM1 mutations can prevent or slow the development of bone lesions with an adverse event profile that is acceptable.Trial registration numberISRCTN11616770.

Project description:Recommendations for antenatal calcium supplementation to prevent preeclampsia could substantially reduce maternal mortality, but adherence to multiple daily doses may constrain effectiveness. World Health Organization guidelines recommend 3 daily calcium supplements (1.5-2 g/d), taken separately from 1 iron-folic acid (IFA) supplement; however, limited data suggest lower calcium doses may also be effective. We conducted mixed-methods household trials to identify strategies for supporting adherence and integrating calcium into antenatal IFA supplementation programming in Ethiopia. Participants were randomly assigned to 3 regimens varying in dose and timing and were later given a choice of regimens. Semistructured interviews conducted over 6 weeks explored acceptability, barriers, and facilitators and offered opportunities to choose calcium pill type. Interviews were transcribed, translated, and analyzed thematically. Calcium adherence was measured using medication event monitoring. All participants (N=48) agreed to try supplementation. Adherence barriers included forgetting to take pills when busy or travelling and perceived side effects. Midday doses were the most challenging because of farming, market, and social events; women avoided taking supplements in public due to fear of being perceived as HIV positive. Social support from families, visual reminders, and anticipated benefits motivated adherence. More participants (75%) selected chewable versus conventional supplements due to organoleptic properties, but this preference declined over time. Adherence rates did not substantially differ across regimens with 2 (81.1%), 3 (83.4%), or 4 (77.1%) pill-taking events. Women indicated that the 2-event regimen was more acceptable than 3- and 4-event regimens, but this acceptability was not associated with higher adherence. Consequently, mean daily calcium consumption (811.3 mg) was lower than for 3-event (1,251.1 mg) and 4-event (1,156.4 mg) regimens. Integrating calcium into antenatal IFA supplementation is acceptable to Ethiopian women, with a 3-event regimen yielding the highest consumption rates. Despite women experiencing challenges with midday dosing and stigma, using simple home-based strategies and being counseled on the purpose of supplementation were more effective than reducing dosage for mitigating barriers and improving adherence.

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Effect of zoledronic acid on serum calcium in Paget's disease patients after educational strategies to improve calcium and vitamin D supplementation.

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Effect of zoledronic acid on serum calcium in Paget's disease patients after educational strategies to improve calcium and vitamin D supplementation.

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