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THE CLINICAL CHARACTERISTICS AND EFFICACY OF BISPHOSPHONATES IN AUDLT PATIENTS WITH OSTEOGENESIS IMPERGECTA.
Endocr Pract. 2016 11; 22(11):1267-1276.EP

Abstract

OBJECTIVE

Osteogenesis imperfecta (OI) is characterized by low bone mass and recurrent fractures. Adults with OI are often treated with oral or intravenous bisphosphonates (BPs). We investigated the clinical phenotypes of adult OI patients and prospectively compared the efficacy of oral alendronate (ALN) with intravenous zoledronic acid (ZOL) in OI patients.

METHODS

This 24-month, observational, randomized clinical study included 60 adult patients with OI. We compared the differences in bone mineral density (BMD) and bone turnover biomarkers between OI adults and healthy subjects. Thereafter, OI patients were randomized at a 2:1 ratio to receive either weekly oral ALN 70 mg or once-yearly infusion of ZOL 5 mg. The efficacy outcomes were changes in BMD, bone turnover biomarkers, and fracture incidence.

RESULTS

Adult OI patients had significantly lower BMD and significantly higher cross-linked C-telopeptide of type I collagen (β-CTX) levels than age-/sex-/BMI-matched healthy subjects. A total of 52 patients completed the 24-month clinical study. BMD at lumbar spine, femoral neck, and total hip were equivalently elevated in the ALN (10.5, 13.2, and 14.7%, respectively) and ZOL (11.3, 13.7, and 11.7%, respectively; all P>.05) groups. Serum alkaline phosphatase decreased by 30.3% in the ALN group and 37.3% in the ZOL group (P = .12), and β-CTX decreased by 58.0% in the ALN group and 63.6% in the ZOL group (P = .48). Compared to the prior fracture rates, clinical fracture incidences were decreased in the ALN and ZOL groups (both P<.05).

CONCLUSION

Adults with OI present significantly lower bone mass and higher bone resorption biomarkers than healthy populations. Oral ALN and intravenous ZOL are equally effective at increasing BMD and inhibiting bone turnover in adults with OI. The treatment may reduce fractures in this study, but further efforts are still needed to demonstrate the anti-fracture efficacy of BPs.

ABBREVIATIONS

25OHD = 25-hydroxyvitamin D ALN = alendronate ALP = alkaline phosphatase BMD = bone mineral density BMI = body mass index BP = bisphosphonate β-CTX = cross-linked C-telopeptide of type I collagen FN = femoral neck LS = lumbar spine OI = osteogenesis imperfecta RCT = randomized controlled trial TH = total hip ZOL = zoledronic acid.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Observational Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27482615

Citation

Xu, Xiao-Jie, et al. "THE CLINICAL CHARACTERISTICS and EFFICACY of BISPHOSPHONATES in AUDLT PATIENTS WITH OSTEOGENESIS IMPERGECTA." Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists, vol. 22, no. 11, 2016, pp. 1267-1276.
Xu XJ, Ma DD, Lv F, et al. THE CLINICAL CHARACTERISTICS AND EFFICACY OF BISPHOSPHONATES IN AUDLT PATIENTS WITH OSTEOGENESIS IMPERGECTA. Endocr Pract. 2016;22(11):1267-1276.
Xu, X. J., Ma, D. D., Lv, F., Wang, J. Y., Liu, Y., Xia, W. B., Jiang, Y., Wang, O., Xing, X. P., Yu, W., & Li, M. (2016). THE CLINICAL CHARACTERISTICS AND EFFICACY OF BISPHOSPHONATES IN AUDLT PATIENTS WITH OSTEOGENESIS IMPERGECTA. Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists, 22(11), 1267-1276.
Xu XJ, et al. THE CLINICAL CHARACTERISTICS and EFFICACY of BISPHOSPHONATES in AUDLT PATIENTS WITH OSTEOGENESIS IMPERGECTA. Endocr Pract. 2016;22(11):1267-1276. PubMed PMID: 27482615.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - THE CLINICAL CHARACTERISTICS AND EFFICACY OF BISPHOSPHONATES IN AUDLT PATIENTS WITH OSTEOGENESIS IMPERGECTA. AU - Xu,Xiao-Jie, AU - Ma,Dou-Dou, AU - Lv,Fang, AU - Wang,Jian-Yi, AU - Liu,Yi, AU - Xia,Wei-Bo, AU - Jiang,Yan, AU - Wang,Ou, AU - Xing,Xiao-Ping, AU - Yu,Wei, AU - Li,Mei, Y1 - 2016/08/02/ PY - 2016/8/3/pubmed PY - 2017/6/21/medline PY - 2016/8/3/entrez SP - 1267 EP - 1276 JF - Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists JO - Endocr Pract VL - 22 IS - 11 N2 - OBJECTIVE: Osteogenesis imperfecta (OI) is characterized by low bone mass and recurrent fractures. Adults with OI are often treated with oral or intravenous bisphosphonates (BPs). We investigated the clinical phenotypes of adult OI patients and prospectively compared the efficacy of oral alendronate (ALN) with intravenous zoledronic acid (ZOL) in OI patients. METHODS: This 24-month, observational, randomized clinical study included 60 adult patients with OI. We compared the differences in bone mineral density (BMD) and bone turnover biomarkers between OI adults and healthy subjects. Thereafter, OI patients were randomized at a 2:1 ratio to receive either weekly oral ALN 70 mg or once-yearly infusion of ZOL 5 mg. The efficacy outcomes were changes in BMD, bone turnover biomarkers, and fracture incidence. RESULTS: Adult OI patients had significantly lower BMD and significantly higher cross-linked C-telopeptide of type I collagen (β-CTX) levels than age-/sex-/BMI-matched healthy subjects. A total of 52 patients completed the 24-month clinical study. BMD at lumbar spine, femoral neck, and total hip were equivalently elevated in the ALN (10.5, 13.2, and 14.7%, respectively) and ZOL (11.3, 13.7, and 11.7%, respectively; all P>.05) groups. Serum alkaline phosphatase decreased by 30.3% in the ALN group and 37.3% in the ZOL group (P = .12), and β-CTX decreased by 58.0% in the ALN group and 63.6% in the ZOL group (P = .48). Compared to the prior fracture rates, clinical fracture incidences were decreased in the ALN and ZOL groups (both P<.05). CONCLUSION: Adults with OI present significantly lower bone mass and higher bone resorption biomarkers than healthy populations. Oral ALN and intravenous ZOL are equally effective at increasing BMD and inhibiting bone turnover in adults with OI. The treatment may reduce fractures in this study, but further efforts are still needed to demonstrate the anti-fracture efficacy of BPs. ABBREVIATIONS: 25OHD = 25-hydroxyvitamin D ALN = alendronate ALP = alkaline phosphatase BMD = bone mineral density BMI = body mass index BP = bisphosphonate β-CTX = cross-linked C-telopeptide of type I collagen FN = femoral neck LS = lumbar spine OI = osteogenesis imperfecta RCT = randomized controlled trial TH = total hip ZOL = zoledronic acid. SN - 1530-891X UR - https://www.unboundmedicine.com/medline/citation/27482615/THE_CLINICAL_CHARACTERISTICS_AND_EFFICACY_OF_BISPHOSPHONATES_IN_AUDLT_PATIENTS_WITH_OSTEOGENESIS_IMPERGECTA_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1530-891X(20)35583-X DB - PRIME DP - Unbound Medicine ER -