Osteoporosis
Reduced bone mineral density (T-score ≤ -2.5 SD on DXA at femoral neck, lumbar spine, or total hip) or a prior low-energy fracture. Per NOF 2022 and SEIOMM 2022, pharmacotherapy is started at T-score ≤ -2.5, after a low-energy fracture, or with FRAX 10-year risk of major osteoporotic fracture ≥20% or hip fracture ≥3%. First-line: bisphosphonates (alendronate, risedronate, zoledronate), then denosumab; romosozumab and teriparatide for severe disease.
ICD-10 M815 drugs
Also known as: Postmenopausal osteoporosis, Senile osteoporosis
Drugs used for this condition
Marketing claims without evidence base
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
- DBoronNot recommended · Trace element with no established human biological role, supplementBoron in «bone» supplements is sold on the basis of 1980s epidemiology linking boron intake to reduced urinary calcium and magnesium excretion. Clinical RCTs showing that boron reduces fracture risk or raises bone mineral density in osteoporosis do not exist. NIH ODS notes «insufficient evidence»; EFSA has not approved any bone-related health claim for boron. Proven options in osteoporosis: dietary calcium plus vitamin D if deficient, resistance exercise, bisphosphonates, denosumab and anabolic therapy in severe cases. If boron was bought or prescribed as osteoporosis treatment, consider seeking a second opinion.
- DCholecalciferol + menaquinone-7 (D3+K2 combo)Not recommended · Combined supplement: fat-soluble vitamins D3 and K2D3+K2 combo is marketed for «bone health» and osteoporosis prevention. Small Japanese trials on K2 (menatetrenone) showed modest fracture reduction in postmenopausal women, but large European RCTs (NPHS, ECKO) did not confirm the effect. ESCEO and NICE recommend in osteoporosis: calcium 1000–1200 mg/day, vitamin D3 800 IU/day, physical activity, and bisphosphonates, denosumab or anabolics in confirmed disease. Additional K2 is not in the recommendation. If the combo was recommended «for bones», discuss evidence-based therapy with your doctor based on DXA and FRAX. Important: vitamin K reduces the effect of warfarin and other vitamin K antagonists; patients on these anticoagulants, including those with a mechanical heart valve, must not take vitamin K supplements without medical agreement.
- DManganeseNot recommended · Trace cofactor mineral used in mineral supplements and parenteral nutritionManganese is a trace element involved in bone metabolism, which is why it is sometimes promoted as a supplement to prevent or treat osteoporosis. The evidence does not show a convincing benefit of manganese for osteoporosis: taking it on its own does not lower fracture risk or rebuild bone density. What does help with osteoporosis are confirmed approaches – enough calcium and vitamin D, weight-bearing and resistance exercise, quitting smoking, and, when indicated, medication prescribed by a doctor such as bisphosphonates. With a balanced diet, manganese deficiency is rare.
- FPhytomenadioneNot recommended · Vitamin K1, haemostatic, antidote for coumarin anticoagulant overdosePhytomenadione (vitamin K1) is marketed «for bone health and osteoporosis prevention», blurring with vitamin K2 marketing. K1 and K2 are biologically distinct: K1 comes from vegetables and goes mainly to the liver for clotting factor synthesis; K2 (menaquinones) is synthesised by gut microbiota and linked to osteocalcin activation in bone. Large K1 RCTs in osteoporosis (ECKO trial 2008, NEJM) showed no fracture reduction. NICE and ESCEO recommend adequate calcium+vitamin D, physical activity and smoking cessation for fracture prevention; in confirmed osteoporosis, bisphosphonates, denosumab or anabolics. If K1 was recommended «for osteoporosis», consider seeking a second opinion. Important: vitamin K reduces the effect of warfarin and other vitamin K antagonists; patients on these anticoagulants, including those with a mechanical heart valve, must not take vitamin K supplements without medical agreement.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- AStrong evidence – first or second line in international guidelines
- BRecommended in selected cases
- CStudy data contradict each other
- DBenefit not proven, no documented harm
- FDocumented harm, or risk without benefit