Strontium Ranelate Returns to UK January 2019

The osteoporosis medication strontium ranelate (SR) will once again be available in the UK from January 2019.

The drug was previously available under the brand Protelos but was pulled from the UK market in August 2017.

Servier, the manufacturer of the drug at the time, decided to cease supplying it to the UK due to loss of sales. Use of the drug in the UK had been limited by the health authorities due to safety concerns about cardiovascular risks. A continuous decline in the number of people being treated with it led to the company's decision.

Pharmaceutical company Aristo has now taken on the manufacturing of strontium ranelate, which will be available for prescription beginning January 2019, for the treatment of severe osteoporosis in postmenopausal women and adult men who are at high risk of fracture.

https://nos.org.uk/news/2018/december/strontium-ranelate-returns-to-the-uk-market/

This is good news for UK patients who wish to take SR. It is also good news for those of us in the USA and Canada, where SR is not available, but strontium citrate (SC) is. Some people taking SC got scared when SR was pulled from the UK and the EU. I have continuously taken SC for 11 years. Below is a link to the package information for Aristo.

Package leaflet: Information for the patient

Strontium ranelate Aristo 2 g

granules for oral suspension

Marketing Authorisation Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

Lindopharm GmbH

Neustraße 82

40721 Hilden

Germany

https://www.drugs.com/uk/strontium-ranelate-aristo-2-g-granules-for-oral-suspension-leaflet.html

Strontium Ranelate Withdrawal from European Countries

Cessation of marketing of Protelos/Osseor: Extract of the letter sent to European Medicine Agency (EMA) and national European Agencies on 10 February 2017

14/03/2017

Similar letters, adapted to local regulations, have been sent to all countries worldwide where Protelos/Osseor® is marketed

PROTELOS/OSSEOR® - Cessation of marketing

On 21 September 2004, Protelos/Osseor^® (strontium ranelate), centrally authorised medicinal product, was granted a Marketing Authorisation by the European Commission for the European Union (EU).

Protelos/Osseor^® is indicated in the treatment of severe osteoporosis in postmenopausal women and in adult men at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.

Les Laboratoires Servier hereby notify the cease of the marketing, permanently, in the European countries where it is currently marketed.
This worldwide and strategic decision is taken for commercial reasons based on the following grounds:

• The restricted indication/limited use of Protelos/Osseor®,
• The continuous decrease of patients treated with Protelos/Osseor®.

Les Laboratoires Servier will cease the distribution of Protelos/Osseor® in August 2017.

Servier, founded in 1954, is the first independent pharmaceutical group. We are present in 140 countries, with more than 21 000 employees, including close to 3000 in R&D.

http://www.servier.com/content/cessation-marketing-protelososseor-extract-letter-sent-european-medicine-agency-ema-and

My note: Those who will no longer be prescribed strontium ranelate can buy nonprescription strontium citrate. 

TBS Result Not Affected by Lumbar Spine Osteoarthritis

Abstract

The effect of lumbar osteoarthritis on bone density and trabecular bone score (TBS) was evaluated cross-sectionally and prospectively in postmenopausal women. Lumbar spine osteoarthritis was graded according to Kellgren and Lawrence grades. Lumbar osteoarthritis was found to increase lumbar spine bone density, but not TBS.

INTRODUCTION:

Lumbar osteoarthritis overestimates lumbar bone density (areal bone mineral density (aBMD)). A new texture parameter, the TBS, has been proposed. Calculation of aBMD uses grey level value, while TBS uses grey level variation. Therefore, our hypothesis was that TBS is not influenced by lumbar spine osteoarthritis.

METHODS:

Menopausal women participating in osteoporosis and ultrasound (OPUS) study were included. They had an aBMD measurement of the spine and hip at baseline and 6-year visit. TBS was calculated on lumbar spine dual-energy X-ray absorptiometry (DXA) scans in an automated manner. The presence of lumbar osteoarthritis was evaluated on baseline radiographs using Kellgren and Lawrence (K&L) classification. Grades range from 0 to 4. In our study, osteoarthritis was defined by at least K&L grade 2.

RESULTS:

This study included 1,254 menopausal women (66.7 ± 7.1 years). Among them, 727 attended the 6-year follow-up visit. Patients with lumbar osteoarthritis had an aBMD higher than those without lumbar osteoarthritis at the lumbar spine, but not at the hip. However, the aBMD significantly increased in all sites with the grade of K&L. In contrast, spine TBS was not different between patients with and without lumbar osteoarthritis (p = 0.70), and it was not correlated with K&L grade. Spine TBS and aBMD at all sites were negatively correlated with age (p < 0.0001). Body mass index was correlated positively with aBMD and negatively with spine TBS (p < 0.0001). The 6-year change of aBMD was significant in the hip and nonsignificant in the lumbar spine. That of TBS was significant, with a 3.3 % decrease (p < 0.0001), independent of K&L grade (p = 0.28).

CONCLUSION:

In postmenopausal women, lumbar osteoarthritis leads to an increase in lumbar spine aBMD. In contrast, spine TBS is not affected by lumbar osteoarthritis.

 http://www.ncbi.nlm.nih.gov/pubmed/24687386

Trabecular Bone Score

"The trabecular bone score (TBS) is a gray-level textural metric that can be extracted from the two-dimensional lumbar spine dual-energy X-ray absorptiometry (DXA) image. TBS is related to bone microarchitecture and provides skeletal information that is not captured from the standard bone mineral density (BMD) measurement. Based on experimental variograms of the projected DXA image, TBS has the potential to discern differences between DXA scans that show similar BMD measurements. An elevated TBS value correlates with better skeletal microstructure; a low TBS value correlates with weaker skeletal microstructure. Lumbar spine TBS has been evaluated in cross-sectional and longitudinal studies."

"The following conclusions are based upon publications reviewed in this article:
1) TBS gives lower values in postmenopausal women and in men with previous fragility fractures than their nonfractured counterparts;
2) TBS is complementary to data available by lumbar spine DXA measurements;
3) TBS results are lower in women who have sustained a fragility fracture but in whom DXA does not indicate osteoporosis or even osteopenia;
4) TBS predicts fracture risk as well as lumbar spine BMD measurements in postmenopausal women;
5) efficacious therapies for osteoporosis differ in the extent to which they influence the TBS;
6) TBS is associated with fracture risk in individuals with conditions related to reduced bone mass or bone quality."

"Based on these data, lumbar spine TBS holds promise as an emerging technology that could well become a valuable clinical tool in the diagnosis of osteoporosis and in fracture risk assessment."
http://www.ncbi.nlm.nih.gov/pubmed/24443324

Women's Mid-Life Non-Traumatic Fracture Risk Higher With Low Vitamin D

The lower a woman's vitamin D levels as she transitions to menopause, the greater her risk of sustaining a non-traumatic fracture. 

"Women who have levels less than 20 nanograms per milliliter would need some type of vitamin D supplementation," Dr. Jane A. Cauley of the University of Pittsburgh, who worked on the study, told Reuters Health. The findings back up the Institute of Medicine's conclusion that levels lower than 20 ng/ml are insufficient for skeletal health, she added.

Bone loss is known to accelerate during the menopausal transition, and postmenopausal women require significantly more calcium to reach neutral calcium balance than perimenopausal women, Dr. Cauley and her team note in their report, online February 23 in the Journal of Clinical Endocrinology and Metabolism.

To determine if serum 25(OH)D levels would be associated with changes in bone mineral density (BMD) and fracture risk, the researchers looked at data from the Study of Women's Health Across the Nation (SWAN) on 124 women with an incident traumatic fracture, 88 with an incident non-traumatic fracture, and 1,532 who did not sustain fractures during the study's average follow-up period of 9.5 years. 

Each woman had her serum 25(OH)D level checked at her third annual visit, while her BMD was assessed annually. The women's mean age at the study's outset was 48.5.

The study participants' mean 25(OH)D levels were 21.8 ng/ml, and 43% had levels below 20 ng/mL. While multivariate analysis found no association between 25(OH)D levels and traumatic fracture risk, the risk of non-traumatic fractures decreased by 28% for every 10 ng/ml increase in serum 25(OH)D. [Referring to Table 3 of the original article, “For every 10 ng/ml increase in 25(OH)D, the hazard ratio (HR) for nontraumatic fracture was 0.72 (0.54, 0.95).”; 1.00 minus 0.72 equals 0.28, or 28%]

Women with levels of 20 ng/ml or higher had a 46% lower risk of fracture during follow-up than women with lower levels of 25(OH)D. However, there was no association between baseline 25(OH)D and changes in BMD at the lumbar spine or femoral neck across menopause.

Roughly 22% of the women in the study had vitamin D levels greater than 30 ng/ml, Dr. Cauley said, so the study lacked power to determine if these women's non-traumatic fracture risk was further reduced.
"We didn't see any relationship between 25(OH)D and these bone changes, but we were somewhat limited in that we didn't have any information on how vitamin D changed across menopause," she added.



http://www.nutrition411.com/news/womens-mid-life-non-traumatic-fracture-risk-higher-low-vitamin-d
http://www.medscape.com/viewarticle/841028?src=wnl_edit_tpal&uac=127701PY:
http://press.endocrine.org/doi/pdf/10.1210/jc.2014-4367

Similarities in Acquired Factors Related to Postmenopausal Osteoporosis and Sarcopenia

“Sarcopenia, that is, muscle wasting, and osteoporosis,

that is, fragile bone disease, are significant health burdens

among the postmenopausal women. The prevalence of sarcopenia

has been reported to be 10% to 40% in postmenopausal

population depending on the reference method used and the population.

Osteoporosis affects approximately 30% of (the) female population

over 50 years (of age). Sarcopenia results in decline in activities of

daily living, quality of life, and self-rated health and increases falls and related

skeletal fractures which have been estimated to have deep impact of social

and healthcare-related costs of the postmenopausal population.”

“The present paper focuses on similarities in acquired

factors associated with postmenopausal osteoporosis and

sarcopenia concentrating on decades after the menopausal

transition. Consequently, essential aspects on the effects of

aging on sarcopenia and osteoporosis will be covered.”

“Postmenopausal women are at risk of both osteoporosis

and sarcopenia. There is evidence that these two conditions

coexists and share similar risk factors. Both sarcopenia

and osteoporosis are strongly linked not only to aging

but also to estrogen depletion and thereby to menopausal

transition. This makes the postmenopausal population a

significant target group for prevention of both sarcopenia

and osteoporosis.”

“While the associations between muscle strength, muscle

mass, and functional capacity with clinically relevant endpoint

of osteoporosis, that is, BMD and fractures, have been

reported, there are no studies addressing the associations

between three stages of clinical sarcopenia, that is, presarcopenia,

sarcopenia, and severe sarcopenia. The associations

of the three modalities of sarcopenia with osteopenia,

osteoporosis, and severe osteoporosis remain unexplored.

An essential part of the diagnosis of both osteoporosis

and sarcopenia includes DXA, which allows simultaneous

assessment of both conditions. The future research should

concentrate on exploring the clinically relevant dimensions

and interactions of sarcopenia and osteoporosis.”

To read the full review article by Joonas Sirola and Heikki Kröger:

http://www.hindawi.com/journals/jos/2011/536735/