Osteoporosis future or investigational therapies: Difference between revisions
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==Overview== | ==Overview== | ||
Some future antiresorptive drugs that are not yet improved by [[FDA]], include [[calcitriol]], [[genistein]], other [[bisphosphonates]] ([[etidronate]], [[pamidronate]], and [[tiludronate]]), [[PTH]] (1-84), [[sodium fluoride]], [[strontium ranelate]], and also [[tibolone]]. | |||
==Future or Investigational Therapies== | ==Future or Investigational Therapies== | ||
===Non-FDA-approved drugs for osteoporosis=== | |||
* | Nonapproved agents include: | ||
* | *'''Calcitriol''': This synthetic [[vitamin D]] analogue, which promotes [[calcium]] absorption, has been approved by the [[FDA]] for managing [[hypocalcemia]] and metabolic [[bone]] [[disease]] in renal [[dialysis]] patients. It is also approved for use in [[hypoparathyroidism]], both surgical and [[idiopathic]], and [[pseudohypoparathyroidism]]. No reliable data demonstrate a reduction of risk for osteoporotic [[fracture]]. | ||
*'''Genistein''': An [[isoflavone]] [[phytoestrogen]] which is the main ingredient in the prescription “medical food” product Fosteum® and generally regarded as safe by the FDA. [[Genistein]] may benefit [[bone]] health in [[postmenopausal]] women but more data are needed to fully understand its effects on [[bone]] health and [[fracture]] risk. | |||
*'''Other bisphosphonates (etidronate, pamidronate, tiludronate)''': These medications vary chemically from [[alendronate]], [[ibandronate]], [[risedronate]], and [[zoledronic acid]] but are in the same drug class. At this time, none is approved for prevention or treatment of [[osteoporosis]]. Most of these medications are currently approved for other conditions (e.g., [[Paget’s disease]], [[hypercalcemia]] of [[malignancy]], [[myositis ossificans]]). | |||
*'''PTH (1-84)''': This [[medication]] is approved in some countries in Europe for treatment of [[osteoporosis]] in women. In one clinical study, [[PTH]] (1-84) effectively reduced the risk of [[vertebral fractures]] at a dose of 100 mcg/ day. | |||
*'''Sodium fluoride''': Through a process that is still unclear, [[sodium fluoride]] stimulates the formation of new [[bone]]. The quality of [[bone mass]] thus developed is uncertain, and the evidence that [[fluoride]] reduces [[fracture]] risk is conflicting and controversial. | |||
*'''Strontium ranelate''': This medication is approved for the treatment of [[osteoporosis]] in some countries in Europe. [[Strontium ranelate]] reduces the risk of both [[spine]] and nonvertebral [[fractures]], but the mechanism is unclear. Incorporation of [[strontium]] into the crystal structure replacing [[calcium]] may be part of its mechanism of effect. These effects have only been documented with the [[pharmaceutical]] grade agent produced by [[Servier Laboratories|Servier]]. This effect has not been studied in nutritional supplements containing [[strontium]] salts. | |||
*'''Tibolone''': [[Tibolone]] is a tissue-specific, [[estrogen]]-like agent that may prevent [[bone loss]] and reduce [[menopausal]] symptoms. It is indicated in Europe for the treatment of [[vasomotor]] symptoms of [[menopause]] and for prevention of [[osteoporosis]], but it is not approved for use in the USA.<ref name="Cosmande Beur2014">{{cite journal|last1=Cosman|first1=F.|last2=de Beur|first2=S. J.|last3=LeBoff|first3=M. S.|last4=Lewiecki|first4=E. M.|last5=Tanner|first5=B.|last6=Randall|first6=S.|last7=Lindsay|first7=R.|title=Clinician’s Guide to Prevention and Treatment of Osteoporosis|journal=Osteoporosis International|volume=25|issue=10|year=2014|pages=2359–2381|issn=0937-941X|doi=10.1007/s00198-014-2794-2}}</ref> | |||
==References== | ==References== | ||
{{Reflist|2}} | {{Reflist|2}} | ||
Revision as of 22:11, 16 August 2017
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Cafer Zorkun, M.D., Ph.D. [2], Raviteja Guddeti, M.B.B.S.[3]
Overview
Some future antiresorptive drugs that are not yet improved by FDA, include calcitriol, genistein, other bisphosphonates (etidronate, pamidronate, and tiludronate), PTH (1-84), sodium fluoride, strontium ranelate, and also tibolone.
Future or Investigational Therapies
Non-FDA-approved drugs for osteoporosis
Nonapproved agents include:
- Calcitriol: This synthetic vitamin D analogue, which promotes calcium absorption, has been approved by the FDA for managing hypocalcemia and metabolic bone disease in renal dialysis patients. It is also approved for use in hypoparathyroidism, both surgical and idiopathic, and pseudohypoparathyroidism. No reliable data demonstrate a reduction of risk for osteoporotic fracture.
- Genistein: An isoflavone phytoestrogen which is the main ingredient in the prescription “medical food” product Fosteum® and generally regarded as safe by the FDA. Genistein may benefit bone health in postmenopausal women but more data are needed to fully understand its effects on bone health and fracture risk.
- Other bisphosphonates (etidronate, pamidronate, tiludronate): These medications vary chemically from alendronate, ibandronate, risedronate, and zoledronic acid but are in the same drug class. At this time, none is approved for prevention or treatment of osteoporosis. Most of these medications are currently approved for other conditions (e.g., Paget’s disease, hypercalcemia of malignancy, myositis ossificans).
- PTH (1-84): This medication is approved in some countries in Europe for treatment of osteoporosis in women. In one clinical study, PTH (1-84) effectively reduced the risk of vertebral fractures at a dose of 100 mcg/ day.
- Sodium fluoride: Through a process that is still unclear, sodium fluoride stimulates the formation of new bone. The quality of bone mass thus developed is uncertain, and the evidence that fluoride reduces fracture risk is conflicting and controversial.
- Strontium ranelate: This medication is approved for the treatment of osteoporosis in some countries in Europe. Strontium ranelate reduces the risk of both spine and nonvertebral fractures, but the mechanism is unclear. Incorporation of strontium into the crystal structure replacing calcium may be part of its mechanism of effect. These effects have only been documented with the pharmaceutical grade agent produced by Servier. This effect has not been studied in nutritional supplements containing strontium salts.
- Tibolone: Tibolone is a tissue-specific, estrogen-like agent that may prevent bone loss and reduce menopausal symptoms. It is indicated in Europe for the treatment of vasomotor symptoms of menopause and for prevention of osteoporosis, but it is not approved for use in the USA.[1]
References
- ↑ Cosman, F.; de Beur, S. J.; LeBoff, M. S.; Lewiecki, E. M.; Tanner, B.; Randall, S.; Lindsay, R. (2014). "Clinician's Guide to Prevention and Treatment of Osteoporosis". Osteoporosis International. 25 (10): 2359–2381. doi:10.1007/s00198-014-2794-2. ISSN 0937-941X.