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Cialis and Bone Health: What Tadalafil Does to Bone Density

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At a glance

  • Approved uses / ED and BPH as Cialis; PAH as Adcirca 20 mg tablets [1][2]
  • Reported musculoskeletal reactions / Back pain 3% on placebo vs 6% on tadalafil 20 mg as needed; myalgia 1% vs 3% [1]
  • Time course of back pain / Usually began 12 to 24 hours after dosing and resolved within 48 hours [1]
  • Hormones / No adverse effect on mean testosterone, LH or FSH vs placebo with tadalafil 10 or 20 mg [1]
  • Daily dosing / Steady state within 5 days; exposure about 1.6-fold that of a single dose [1]
  • Bone screening criteria / Endocrine Society: central DXA for men 70 and older and men 50 to 69 with risk factors [3]

Does tadalafil affect bone density?

The trials behind approval did not report a bone outcome. They measured erectile function in 1,112 men across five 12-week trials [4], urinary symptom scores in men with BPH [5], and six-minute walk distance in pulmonary arterial hypertension [6]. None of those trials reported bone density, bone turnover markers or fractures, so they cannot show whether tadalafil affects bone in either direction.

What the Cialis label reports

In the eight 12-week placebo-controlled trials of as-needed Cialis for ED, back pain was reported by 3% of men on placebo and by 3%, 5% and 6% of men on tadalafil 5, 10 and 20 mg; myalgia by 1% on placebo and 1%, 4% and 3% at those doses [1]. Back pain and myalgia usually began 12 to 24 hours after a dose and typically resolved within 48 hours [1]. These are reports of back and muscle pain, not measurements of bone.

The label's warnings cover cardiovascular risk during sexual activity, priapism, sudden vision loss that could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), sudden hearing loss, and additive blood pressure lowering with nitrates, alpha-blockers, antihypertensives and alcohol [1]. For vision, the label says patients should stop Cialis and seek medical care if sudden loss of vision occurs in one or both eyes [1].

Does tadalafil change testosterone?

The label reports no adverse effect of tadalafil 10 or 20 mg on mean testosterone, luteinizing hormone or follicle-stimulating hormone concentrations compared with placebo [1]. Tadalafil is a PDE5 inhibitor, not a testosterone product, and low testosterone is not an approved indication for it [1].

How bone screening is decided for men

The Endocrine Society's 2012 guideline on osteoporosis in men recommends central dual-energy x-ray absorptiometry for men aged 70 and older, and for men aged 50 to 69 who have risk factors such as low body weight, a prior fracture as an adult, or smoking. It also recommends laboratory testing to detect contributing causes, adequate calcium and vitamin D, weight-bearing exercise, and monitoring treatment with serial DXA [3]. Those criteria rest on age and risk factors, and they apply whether or not a man takes tadalafil.

Frequently asked questions

Does Cialis cause bone loss?
The label's trial tables list reactions in at least 2% of patients, and bone loss and fracture are not among them. The most common are headache, dyspepsia, back pain, myalgia, nasal congestion, flushing and pain in limb, with back pain reported by 3% of men on placebo and 6% on tadalafil 20 mg as needed [1].
Does tadalafil affect testosterone?
The label reports no adverse effect of tadalafil 10 or 20 mg on mean testosterone, luteinizing hormone or follicle-stimulating hormone concentrations versus placebo [1]. Tadalafil is a PDE5 inhibitor approved for erectile dysfunction, BPH and pulmonary arterial hypertension, not a testosterone treatment [1][2].
Can tadalafil be taken with osteoporosis drugs?
The label's interaction list names no osteoporosis drugs. Its listed interactions include nitrates, which are contraindicated, alpha-blockers, certain blood pressure medicines, alcohol, and CYP3A4 inhibitors or inducers such as ketoconazole and rifampin [1].
Who is recommended for bone density screening?
The Endocrine Society's 2012 guideline recommends central dual-energy x-ray absorptiometry for men aged 70 and older and for men aged 50 to 69 with risk factors such as low body weight, a prior fracture as an adult or smoking, along with adequate calcium and vitamin D, weight-bearing exercise and serial DXA monitoring [3].

References

  1. U.S. National Library of Medicine, DailyMed. Cialis (tadalafil) tablets, Lilly prescribing information. Cialis (tadalafil) tablets, Lilly label
  2. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  3. Watts NB, Adler RA, Bilezikian JP, Drake MT, Eastell R, Orwoll ES, et al. Osteoporosis in men: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012;97(6):1802-22. Osteoporosis in men: an Endocrine Society clinical practice guideline
  4. Brock GB, McMahon CG, Chen KK, Costigan T, Shen W, Watkins V, et al. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol. 2002;168(4 Pt 1):1332-6. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses
  5. Porst H, Kim ED, Casabé AR, Mirone V, Secrest RJ, Xu L, et al. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial. Eur Urol. 2011;60(5):1105-13. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial
  6. Galiè N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, et al. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009;119(22):2894-903. Tadalafil therapy for pulmonary arterial hypertension
Evidence overview for cialis tadalafil: Cialis and Bone Health: What Tadalafil Does to Bone Density