Strontium ranelate for preventing and treating postmenopausal osteoporosis

  • Review
  • Intervention




Strontium ranelate is a new treatment for osteoporosis therefore, its benefits and harms need to be known.


To determine the efficacy and safety of strontium ranelate for the treatment and prevention of postmenopausal osteoporosis.

Search methods

We searched MEDLINE (1996-March 2005), EMBASE (1996-week 9 2005), the Cochrane Library (1996-Issue 1 2005), reference lists of relevant articles and conference proceedings from the last two years. Additional data was sought from authors.

Selection criteria

We included randomized controlled trials (RCTs) of at least one year duration comparing strontium ranelate to placebo and reporting fracture incidence, bone mineral density (BMD) or adverse events in postmenopausal women. Treatment population was defined as women with prevalent vertebral fractures and/or lumbar spine BMD T-score < -2.5 SD.

Data collection and analysis

Two reviewers independently determined study eligibility, assessed study validity, graded the evidence and extracted relevant data. Disagreements were resolved by consensus. RCTs were grouped by dose and treatment duration. Where possible, meta-analysis was conducted using the random effects model.

Main results

Four trials met the inclusion criteria. Three had losses to follow-up > 20% and only one provided an adequate description of allocation concealment. Three included a treatment population (0.5 to 2 g/day of strontium ranelate) and one a prevention population (0.125, 0.5 and 1 g/day). A 37% reduction in vertebral fractures (RR 0.63, 95% CI 0.56, 0.71), and a 14% reduction in non-vertebral fractures with the upper boundary of the confidence interval approaching one (RR 0.86, 95% CI 0.75, 0.98), were demonstrated over three years with 2 g of strontium ranelate daily in a treatment population. An increase in BMD was shown at all sites after two to three years of treatment in both populations. Lower doses of strontium ranelate were superior to placebo and the highest dose demonstrated the greatest reduction in vertebral fractures and increase in BMD. An increased risk of diarrhea with 2 g of strontium ranelate daily was found; however, adverse events did not affect the risk of discontinuing treatment nor did it increase the risk of serious side effects, gastritis or death. Additional data suggests that the risk of vascular and nervous system side-effects is increased with taking 2 g of strontium ranelate daily over three to four years.

Authors' conclusions

There is silver level evidence ( to support the efficacy of strontium ranelate for the reduction of fractures (vertebral and to a lesser extent, non-vertebral) in postmenopausal osteoporotic women and an increase in BMD in postmenopausal women with/without osteoporosis. Diarrhea may occur, however, adverse events leading to study withdrawal were not significantly increased. Potential vascular and neurological side-effects need to be further explored.



Strontium ranelate治療及及預防停經後婦女骨質疏鬆症

Strontium ranelate是一種治療骨質疏鬆症的新藥物,因此須知道其益處與害處。


研究Strontium ranelate治療及預防停經後婦女骨質疏鬆症的效果與害處。


搜尋包括MEDLINE (1996 to March 2005), EMBASE (1996 to week 9 2005), the Cochrane Library (1996 to Issue 1 2005)。同時手動搜尋所選文章之參考文獻及會議報告,並詢問作者。


隨機對照試驗Strontium ranelate與安慰劑至少使用一年比較停經後婦女骨折發生率、骨質密度(BMD)、健康相關生活品質指標或安全性。治療族群﹝比預防族群﹞定義為脊椎骨折及或腰椎骨密度 T值小於負2.5標準差。




4個研究包含於分析中,其中3篇為治療族群 (每日strontium ranelate 0.5 to 2 g) 及1篇預防族群(每日0.125 g, 0.5 g and 1 g)。每日2公克 strontium ranelate治療,脊椎骨折3年減少37% ,(RR 0.63, 95% CI 0.56, 0.71)及非脊椎骨折3年減少14% (RR 0.86, 95% CI 0.75, 0.98)。 兩族群治療2到3年後各地骨質密度皆增加。低劑量比安慰劑好,給高劑量顯示效果最好。但每日2公克 strontium ranelate拉肚子副作用增加,但未影響退出使用機會,且未增加嚴重副作用、胃炎或死亡的風險。進一步資料建議每日2公克 strontium ranelate3到4年,對血管及神經系統副作用稍有增加。


銀級證據支持strontium ranelate減少在停經後婦女骨折(脊椎及一部分非脊椎)及增加骨質密度。每日2公克 strontium ranelate拉肚子副作用機會增加,但未影響退出研究,潛在血管及神經系統副作用風險需進一步研究。



此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。


Strontium ranelate治療及及預防停經後婦女骨質疏鬆症 此Cochrane review摘要了我們所知道有關Strontium ranelate對於停經後婦女骨質疏鬆症的效果。Review表明:有銀級證據(認為停經後婦女使用Strontium ranelate每天2克超過 3年可以減少脊柱骨折和輕微減少非脊椎骨折。大多數婦女沒有會促使他們停止服用Strontium ranelate的副作用。然而,其他研究表明,藥物的危害可能包括增加血液凝塊的機會和癲癇,記憶力喪失和意識不清。什麼是骨質疏鬆症,以及Strontium ranelate如何有作用呢?骨質疏鬆症是一種骨質流失的狀況。骨質流失導致骨骼脆弱,容易折斷,甚至是在日常的活動。脊椎骨斷(骨折)和非脊柱骨折(如腕關節和髖關節)是最常見的類型。有許多藥物和礦物質被用來治療骨質疏鬆症。Strontium ranelate是一種藥物,可減緩骨質流失,並可能通過建立新骨來降低骨折的機會。這是一個新的藥物,因此它的好處與壞處必須被知道。這次review的結果是什麼呢?本研究的婦女會服用Strontium ranelate 2克或安慰劑(假錠劑或藥粉)。經過 2至3年,骨折發生數量和骨密度會被測定。骨礦物密度是實驗室測試,以衡量在臀部,脊椎或頸部骨頭的密集度或強壯度。骨質密度越高越好 Strontium ranelate對於停經後婦女骨質疏鬆症的好處: ‧Strontium ranelate減少脊柱骨折 每100名接受了Strontium ranelate婦女有13位有脊椎骨折 每100名接受了安慰劑婦女有21位有脊椎骨折 ‧Strontium ranelate可以降低非脊椎骨折 每100名接受了Strontium ranelate婦女有10位有非脊椎骨折 每100名接受了安慰劑婦女有12位有非脊椎骨折 ‧Strontium ranelate增加骨密度 3個接受了Strontium ranelate婦女中有一個增加脊椎和髖骨骨密度 Strontium ranelate的壞處 在有骨質疏鬆症的停經後婦女: ‧Strontium ranelate並未造成會使他們停止服用的副作用 ‧Strontium ranelate並沒有導致嚴重的副作用,胃感染,下背痛或死亡 ‧Strontium ranelate增加腹瀉 每100名接受了Strontium ranelate婦女有6位有腹瀉 每100名接受了安慰劑婦女有4位腹瀉 其他研究表明,危害可能包括血液凝塊的機會,和癲癇,記憶力喪失和意識不清。這些神經副作用的原因尚不清楚。這次回顧有幾個限制,包括由於strontium在骨中獨特造成難以解釋的骨礦物密度變化,個別試驗中有一些病人是不完整後續追蹤的。


















監  訳: 林 啓一,2008.1.11

実施組織: 厚生労働省委託事業によりMindsが実施した。

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Plain language summary

Strontium ranelate for osteoporosis in women after menopause

This summary of a Cochrane review presents what we know from research about the effect of strontium ranelate for osteoporosis in women after menopause. The review shows that:
There is silver level evidence ( that for treatment of osteoporosis in women after menopause, 2 g of strontium ranelate daily over 3 years decreases fractures in the spine and slightly decreases fractures not in the spine. Most women do not have side effects that would cause them to stop taking strontium ranelate. However, other research shows that harms could include a chance of blood clots and seizures, memory loss and consciousness.

What is osteoporosis and how can strontium ranelate help?

Osteoporosis is a condition in which bone loss occurs. Bone loss leads to weak brittle bones that can break easily, even during everyday activities. Breaks (fractures) of the spine or non-spine (e.g. wrist and hip) are the most common type. There are many drugs and minerals that work to treat osteoporosis. Strontium ranelate is a drug that decreases the chance of fractures by slowing the loss of bone and possibly by building new bone. It is a new drug and therefore its benefits and harms need to be known.

What are the results of this review?

Women in the studies took 2 g of strontium ranelate or a placebo (fake tablets or powder). After 2 to 3 years, the number of fractures that occurred and bone mineral density was measured. Bone mineral density is a lab test to measure how dense or strong bones are in the hip, spine or neck. The higher the bone density the better.

Benefits of strontium ranelate

In women after menopause who have osteoporosis:

- strontium ranelate decreases spine fractures:

13 out of 100 women had spine fractures taking strontium ranelate

21 out of 100 women had spine fractures taking a placebo

- strontium ranelate may decrease fractures that are not in the spine:

10 out of 100 women had non-spine fractures taking strontium ranelate

12 out of 100 women had non-spine fractures taking a placebo

- strontium ranelate increases bone mineral density

1 in 3 women had an increase in spine and hip bone mineral density taking strontium ranelate

Harms of strontium ranelate

In women after menopause who have osteoporosis:

- strontium ranelate did not cause side effects that would make them stop taking it

- strontium ranelate did not lead to serious side effects, stomach infections, back pain or death

- strontium ranelate increased diarrhea

6 out of 100 women had diarrhea taking strontium ranelate

4 out of 100 women had diarrhea taking a placebo

Other research shows that harms could include a chance of blood clots, and seizures, memory loss and consciousness. The cause of these vascular and neurological side effects are not known.

This review has several limitations which include difficulty interpreting the change in bone mineral density due to the unique aspects of strontium in bone as well, incomplete follow-up of some patients within the individual trials.