Strontium ranelate

Strontium ranelate
Clinical data
Trade names	Protelos, Osseor
AHFS/Drugs.com	UK Drug Information
License data	EU EMA: by INN;
Pregnancy; category	Only intended for use in postmenopausal women, no data on exposed pregnancies. If strontium ranelate is used inadvertently during pregnancy, treatment must be stopped.;
Routes of; administration	By mouth
ATC code	M05BX03 (WHO) ;
Legal status
Legal status	UK: POM (Prescription only);
Pharmacokinetic data
Bioavailability	25% (range 19–27%)
Protein binding	25% for plasma protein and high affinity for bone tissue
Metabolism	As a divalent cation, strontium is not metabolised. Does not inhibit cytochrome P450 enzymes
Elimination half-life	60 hours
Excretion	Renal and gastrointestinal. Plasma clearance is about 12 ml/min (CV 22%) and renal clearance about 7 ml/min (CV 28%)
Identifiers
	IUPAC name distrontium 5-[bis(2-oxido-2-oxoethyl)amino]-4-cyano-; 3-(2-oxido-2-oxoethyl)thiophene-2-carboxylate;
CAS Number	135459-87-9 ;
PubChem CID	6918182;
ChemSpider	5293393 ;
UNII	04NQ160FRU;
KEGG	D08468 ;
CompTox Dashboard (EPA)	DTXSID40872400 ;
ECHA InfoCard	100.218.275
Chemical and physical data
Formula	C12H6N2O8SSr2
Molar mass	513.49 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES [Sr+2].[Sr+2].O=C([O-])CN(c1sc(c(c1C#N)CC([O-])=O)C([O-])=O)CC([O-])=O;
	InChI InChI=1S/C12H10N2O8S.2Sr/c13-2-6-5(1-7(15)16)10(12(21)22)23-11(6)14(3-8(17)18)4-9(19)20;;/h1,3-4H2,(H,15,16)(H,17,18)(H,19,20)(H,21,22);;/q;2*+2/p-4 ; Key:XXUZFRDUEGQHOV-UHFFFAOYSA-J ;
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Strontium ranelate, a strontium(II) salt of ranelic acid, is a medication for osteoporosis marketed as Protelos or Protos by Servier. Studies indicate it can also slow the course of osteoarthritis of the knee.^[1] The drug is unusual in that it both increases deposition of new bone by osteoblasts and reduces the resorption of bone by osteoclasts. It is therefore promoted as a "dual action bone agent" (DABA).

On 13 May 2013, Servier released a Direct Healthcare Professional Communication which stated that new restrictions for the use of strontium ranelate are now in place, as randomised trials have shown an increased risk of myocardial infarction. Servier states that the use is now restricted to treatment of severe osteoporosis in postmenopausal women at high risk for fracture.^[2] The European Pharmacovigilance Risk Assessment Committee (PRAC) recommended restriction in the use of strontium ranelate, based on a routine benefit-risk assessment of the medicine, which included data showing a possible increased risk of heart problems, including heart attacks.^[3] On 21 February 2014 the European Medicine Agency recommended that strontium ranelate remain available with restrictions relative to patients with existing heart disease.^[4] In 2017, a large study of over 280,000 British and Spanish patients found no increased risk of venous thromboembolism in users of strontium ranelate compared to alendronate.^[5] Servier ceased manufacturing the drug and in 2019, the drug returned the market in the United Kingdom under the name strontium ranelate Aristo.^[6]

^ "New osteoarthritis treatments on the horizon". Harvard Women’s Health Watch. May 2013.
^ "IMB: Publications » Protelos (Strontium ranelate) Important Safety Information from Servier as approved by the Irish Medicines Board". Archived from the original on 2013-09-29. Retrieved 2013-06-25.
^ "EMA/220628/2013 PRAC recommends restriction in the use of Protelos/Osseor" (PDF). European Medicines Agency. 11 April 2013. Archived (PDF) from the original on 2019-07-05. Retrieved 2023-06-25.
^ "European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions". European Medicines Agency. 17 September 2018. Archived from the original on 19 July 2015. Retrieved 16 June 2015.
^ Khalid S, Ali M, Hawley S, Judge A, Arden N, Van Staa T, et al. (April 2017). "Osteoporosis and Metabolic Bone Disease080. Comparative Risk of Venous Thromboembolism Among Users of Different Anti-Osteoporosis Drugs in the UK National Health Service and in Catalonia, Spain: A Propensity-Matched Cohort Study". Rheumatology. 56 (suppl_2). doi:10.1093/rheumatology/kex062.080.
^ "Strontium ranelate Aristo 2g granules for oral suspension - Summary of Product Characteristics (SMPC)". Electronic Medicines Compendium (EMC). Datapharm Ltd.

[1] "New osteoarthritis treatments on the horizon". Harvard Women’s Health Watch. May 2013.

[2] "IMB: Publications » Protelos (Strontium ranelate) Important Safety Information from Servier as approved by the Irish Medicines Board". Archived from the original on 2013-09-29. Retrieved 2013-06-25.

[3] "EMA/220628/2013 PRAC recommends restriction in the use of Protelos/Osseor" (PDF). European Medicines Agency. 11 April 2013. Archived (PDF) from the original on 2019-07-05. Retrieved 2023-06-25.

[4] "European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions". European Medicines Agency. 17 September 2018. Archived from the original on 19 July 2015. Retrieved 16 June 2015.

[5] Khalid S, Ali M, Hawley S, Judge A, Arden N, Van Staa T, et al. (April 2017). "Osteoporosis and Metabolic Bone Disease080. Comparative Risk of Venous Thromboembolism Among Users of Different Anti-Osteoporosis Drugs in the UK National Health Service and in Catalonia, Spain: A Propensity-Matched Cohort Study". Rheumatology. 56 (suppl_2). doi:10.1093/rheumatology/kex062.080.

[6] "Strontium ranelate Aristo 2g granules for oral suspension - Summary of Product Characteristics (SMPC)". Electronic Medicines Compendium (EMC). Datapharm Ltd.

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