The FDA is requiring a boxed warning in the label of denosumab (Prolia – Amgen), a monoclonal antibody that inhibits osteoclasts, about an increased risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD; eGFR <30 mL/min/1.73 m²), particularly those on dialysis. FDA-approved indications for Prolia are listed in Table 1.

Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and safety. The FDA has issued a proposed rule that would require manufacturers to perform additional safety studies for some sunscreen active ingredients and would mandate better UVA protection in sunscreen products. Some sunscreen products containing FDA-approved active ingredients are listed in Table 2.

An oral nonopioid analgesic is often sufficient for acute treatment of mild to moderate migraine headache without severe nausea or vomiting. A triptan is the drug of choice for treatment of moderate to severe migraine headache pain in most patients without vascular disease. Early treatment of pain when it is still mild to moderate in intensity improves headache response and reduces the risk of recurrence.

US guidelines recommend pharmacologic therapy for postmenopausal women with a bone density T-score (standard deviation from normal mean values in healthy young women) of -2.5 or below in the lumbar spine, femoral neck, total hip, or distal radius, a T-score between -1.0 and -2.5 and a history of fragility (low-trauma) fracture of the hip or spine, or a T-score between -1.0 and -2.5 and a FRAX 10-year probability of ≥3% for hip fracture or ≥20% for major osteoporotic fracture (hip, clinical spine, humerus, distal radius).

Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but some questions remain about their effectiveness and safety.

Diagnosis of osteoporosis is based on the results of bone mineral density (BMD) testing or by the occurrence of a fragility fracture. Bone densitometry results are generally reported in terms of standard deviations (SD) from the mean value for young adults (T-score). The World Health Organization (WHO) defines osteoporosis in women as a T-score of -2.5 or below in the spine, femoral neck, or total hip. A computerized model (FRAX) is available that estimates the 10-year probability of a hip fracture or other major osteoporotic fracture based on clinical risk factors and BMD at the femoral neck.

The FDA has approved extended-release (ER) calcifediol (25-hydroxyvitamin D3; Rayaldee – Opko), a prohormone of calcitriol, the active form of vitamin D3. It is indicated for treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) who have serum total 25-hydroxyvitamin D levels <30 ng/mL.

An oral nonopioid analgesic may be sufficient for treatment of mild to moderate migraine without severe nausea or vomiting. A triptan is the drug of choice for treatment of moderate to severe migraine. Use of a triptan early in an attack when pain is still mild to moderate in intensity improves headache response and reduces recurrence rates.

The FDA has approved a subcutaneously injected formulation of recombinant human parathyroid hormone (Natpara – NPS) as an adjunct to calcium and vitamin D to control hypocalcemia in adults with hypoparathyroidism. Natpara is an 84-amino acid single-chain polypeptide identical to native parathyroid hormone. It is the first parathyroid hormone formulation to be approved for this indication.

US guidelines for the treatment of osteoporosis have been published. The diagnosis of osteoporosis has traditionally been established by the occurrence of fragility fractures or by bone densitometry, which is generally reported in terms of standard deviations (SD) from mean values in young adults (T-score). The World Health Organization (WHO) has defined normal bone mineral density (BMD) for women as a value within one SD of the young adult mean. Values 2.5 SD or more below the mean (T-score -2.5 or below) at the spine, femoral neck, or total hip are defined as osteoporosis. The WHO has developed a computerized model (FRAX) that predicts the 10-year probability of a hip fracture or other major osteoporotic fracture based on clinical risk factors and BMD at the femoral neck.

The US Preventive Services Task Force (USPSTF) has issued a Draft Recommendation Statement saying, in effect, that community-dwelling women and men should not take calcium and vitamin D supplements for primary prevention of osteoporotic fractures because the evidence that they are helpful is insufficient and they increase the risk of kidney stones. The Medical Letter has said previously that there is no evidence that patients with an adequate intake of calcium (1000-1200 mg/day) and vitamin D (600-800 IU/day) will benefit from taking supplements.1

1. Drugs for postmenopausal osteoporosis. Treat Guidel Med Lett 2011; 9:67.

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Osteoporosis is characterized by low bone mass with microarchitectural disruption and skeletal fragility that results in an increased risk of fracture. The diagnosis has traditionally been established by bone densitometry, which is generally reported in terms of standard deviations (SD) from mean values in young adults (T score). The World Health Organization (WHO) has defined normal bone mineral density (BMD) for women as a value within one SD of the young adult mean. Values 2.5 SD (T score -2.5) or more below the mean are defined as osteoporosis. The WHO has developed a computerized model (FRAX) that predicts the 10-year probability of hip fracture based on clinical risk factors and BMD at the femoral neck.

The results of a randomized, placebo-controlled trial of calcium and vitamin D supplements in more than 36,000 postmenopausal women, conducted as part of the Women’s Health Initiative (RD Jackson et al. N Engl J Med 2006; 354:669), have been misinterpreted by some patients to mean that they should stop taking such supplements.

At the time of recruitment, the participants in this study had an average daily calcium intake of 1100-1200 mg. They were randomized to take either 1000 mg of calcium carbonate plus 400 IU of vitamin D₃ or a placebo for an average of 7 years. Both groups were permitted to take calcium and vitamin D supplements on their own as well. In the intention-to-treat population, the study supplements increased hip bone density but did not decrease the incidence of hip fractures. The subgroup of women who adhered to the protocol and actually took the study supplements showed a significant reduction in hip fractures compared to the control group.

Men and women over age 50 should have a total calcium intake of about 1200 mg per day (Treat Guidel Med Lett 2005; 3:69). If they need a supplement to achieve that, calcium citrate is more expensive, but it offers some advantages over calcium carbonate: it can be taken without food, causes less GI disturbance and may be less likely to cause kidney stones.

With any calcium salt, vitamin D is necessary for optimal absorption. The recommended minimum daily requirement of vitamin D (vitamin D₃ is preferred) is 400 IU for people 50-70 years old and 600 IU for those over 70. But those infrequently exposed to the sun may need 800- 1000 IU of vitamin D daily, and many experts recommend 800 IU or more for all postmenopausal women.

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Many drugs are now marketed for treatment of postmenopausal osteoporosis, but questions remain about their use.

Many patients ask their physicians whether they should take vitamins. Since the last Medical Letter article on this subject, more data have become available on the benefits and risks of taking vitamin supplements.

Many drugs are now marketed for treatment of post-menopausal osteoporosis (PD Delmas, Lancet 2002; 359:2018). Prevention of this disorder has been complicated by the news that hormone replacement therapy (HRT), which many women have been taking to prevent osteoporosis, increases the incidence of coronary heart disease and that of breast cancer, stroke and pulmonary embolism as well (Medical Letter 2002; 44:78).

Many drugs are now marketed for prevention and treatment of postmenopausal osteoporosis. All regimens should include an adequate intake of calcium and vitamin D.

Claims for the superiority of various calcium supplements are now appearing on television and in the print media. A high calcium intake combined with vitamin D can increase bone density and reduce the incidence of fractures in older women and probably also in men.

The bone mass of an average person reaches a maximum at the age of 25 to 30, stays the same for about 15 years, and then progressively declines at a rate of 0.2% to 0.5% per year. At menopause, women go through a period of increased bone resorption (2% per year) for about 10 years and then resume a gradual rate of bone loss. Current strategies for prevention and treatment of Postmenopausal Osteoporosis include increasing calcium intake to maximize peak bone mass, using antiresorptive drugs to decrease postmenopausal resorption, and using other drugs to stimulate bone systhesis (BL Riggs and LJ Melton, III, N Engl J Med, 327:620, Aug 27, 1992).