FPIN's Clinical Inquiries

Human Parathyroid Hormone for Treating Osteoporosis



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Am Fam Physician. 2012 Feb 1;85(3):online.

Clinical Question

What is the role of human parathyroid hormone in the treatment of osteoporosis in women?

Evidence-Based Answer

Human parathyroid hormone should be used in patients with severe osteoporosis to decrease the rate of vertebral and nonvertebral fractures. (Strength of Recommendation [SOR]: A, based on a systematic review and randomized controlled trial [RCT].) The parathyroid hormone teriparatide (Forteo) should be reserved for patients who do not respond to bisphosphonates or who have severe bone loss. (SOR: C, based on expert opinion.)

Evidence Summary

Teriparatide is a recombinant human parathyroid hormone. It is approved for the treatment of severe osteoporosis that does not respond to other osteoporosis therapies or in patients who do not tolerate other therapies. The dosage is 20 mcg daily by subcutaneous injection for two years.1 The studies included in this summary were funded by the manufacturer of teriparatide, which introduces the possibility of bias.

A systematic review concluded that teriparatide significantly increased bone density in the spine and hip, and significantly reduced the risk of new vertebral and nonvertebral fractures in postmenopausal women with previous vertebral fractures.2  This review included two double-blind RCTs of teriparatide versus alendronate (Fosamax) in postmenopausal women with osteoporosis (Table 13,4). Both studies found statistically significant increases in bone density in the lumbar spine in patients taking teriparatide (P < .001).3,4 Vertebral fractures were not assessed. There was a decrease in nonvertebral fractures over 14 months (number needed to treat [NNT] = 10; 95% confidence interval [CI], 5 to 1,072).4 An RCT of 1,637 postmenopausal women with previous vertebral fractures compared 20 mcg of teriparatide per day with placebo.5 After 18 months, the NNT to prevent one vertebral fracture was 11 (95% CI, 8 to 18). There was a reduction in nonvertebral fractures (NNT = 28; 95% CI, 15 to 469). A follow-up study of 1,262 of the same patients 18 months after they had finished treatment found that the fracture risk reduction persisted after therapy.6 In the posttreatment period, the NNT to prevent a new vertebral fracture was 13 (95% CI, 8 to 18).

Table 1.

Teriparatide vs. Alendronate for Increasing Bone Mineral Density in Postmenopausal Women with Osteoporosis

Study Treatment No. of patients Study duration Difference in increased lumbar spine bone density (favoring teriparatide)

McClung, et al.3

20 mcg of teriparatide (Forteo) per day vs. 10 mg of alendronate (Fosamax) per day

203

18 months

4.8 percent; P < .001

Body, et al.4

40 mcg of teriparatide per day vs. 10 mg of alendronate per day

146

14 months (median)

8.5 percent; P < .001


Information from references 3 and 4.

Table 1.   Teriparatide vs. Alendronate for Increasing Bone Mineral Density in Postmenopausal Women with Osteoporosis

View Table

Table 1.

Teriparatide vs. Alendronate for Increasing Bone Mineral Density in Postmenopausal Women with Osteoporosis

Study Treatment No. of patients Study duration Difference in increased lumbar spine bone density (favoring teriparatide)

McClung, et al.3

20 mcg of teriparatide (Forteo) per day vs. 10 mg of alendronate (Fosamax) per day

203

18 months

4.8 percent; P < .001

Body, et al.4

40 mcg of teriparatide per day vs. 10 mg of alendronate per day

146

14 months (median)

8.5 percent; P < .001


Information from references 3 and 4.

An RCT of 428 men and women with glucocorticoid-induced osteoporosis compared 20 mcg of teriparatide per day with 10 mg of alendronate per day.7 After 36 months, there were fewer new vertebral fractures in the teriparatide group (1.7 versus 7.7 percent; P = .007). The NNT was 16 (95% CI, 9 to 69). The incidence of nonvertebral fractures was similar between the two groups and not statistically significant. Both drugs increased bone mineral density; however, teriparatide had a greater effect than alendronate. There was a statistically significant but small difference in the percentage increase in bone mineral density in the lumbar spine, hip, and femoral neck favoring the teriparatide group (5.7, 2.5, and 2.9 percent difference, respectively; P < .001 for all three sites).

A European observational study of 1,648 postmenopausal women with osteoporosis treated with teriparatide for 18 months found a 47 percent decrease in the fracture risk in the last six months of the study compared with the first six months.8  The NNT to prevent one fracture per year was 20 (95% CI, 14 to 55). Although these studies suggest a slight benefit of teriparatide when compared with alendronate, the retail cost of teriparatide is more than 10 times that of alendronate (Table 2).

Table 2.

Cost Comparison of Select Medications for Osteoporosis

Medication Dosage Cost*

Alendronate (Fosamax)

10 mg orally, once per day

$72 ($95)

Ibandronate (Boniva)

150 mg orally, once per month

NA ($129)

Raloxifene (Evista)

60 mg orally, once per day

NA ($150)

Risedronate (Actonel)

5 mg orally, once per day

NA ($141)

Teriparatide (Forteo)

20 mcg subcutaneously, once per day

NA ($1,016)


NA = not available.

*—Estimated retail price of one month's treatment based on information obtained at http://www.drugstore.com (accessed November 22, 2011). Generic price listed first; brand price listed in parentheses.

Table 2.   Cost Comparison of Select Medications for Osteoporosis

View Table

Table 2.

Cost Comparison of Select Medications for Osteoporosis

Medication Dosage Cost*

Alendronate (Fosamax)

10 mg orally, once per day

$72 ($95)

Ibandronate (Boniva)

150 mg orally, once per month

NA ($129)

Raloxifene (Evista)

60 mg orally, once per day

NA ($150)

Risedronate (Actonel)

5 mg orally, once per day

NA ($141)

Teriparatide (Forteo)

20 mcg subcutaneously, once per day

NA ($1,016)


NA = not available.

*—Estimated retail price of one month's treatment based on information obtained at http://www.drugstore.com (accessed November 22, 2011). Generic price listed first; brand price listed in parentheses.

Recommendations from Others

Practice guidelines from the American College of Obstetricians and Gynecologists recommend teriparatide therapy in patients with osteoporosis that does not respond to antiresorptive therapies, and in patients with severe disease.9 Guidelines from the American College of Physicians recommend that men and women with osteoporosis be offered bisphosphonates as initial treatment, and state that there is good evidence that teriparatide decreases vertebral and nonvertebral fractures.10 The National Osteoporosis Foundation recommends consideration of teriparatide therapy in patients with osteoporosis and a high risk of fracture, such as those taking sustained glucocorticoid therapy.11

Address correspondence to Henry K. Lau, DO, FAAFP, at henry.lau2@nellis.af.mil. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations to disclose.

The opinions and assertions contained herein are the private views of the authors, and are not to be construed as official, or as reflecting the views of the U.S. Air Force Medical Service or the U.S. Air Force at large.


Copyright Family Physicians Inquiries Network. Used with permission.

REFERENCES

1. Forteo (teriparatide) [package insert]. Indianapolis, Ind.: Eli Lilly; 2010. http://pi.lilly.com/us/forteo-pi.pdf. Accessed December 2, 2011.

2. Cranney A, Papaioannou A, Zytaruk N, et al.; Clinical Guideline Committee of Osteoporosis Canada. Parathyroid hormone for the treatment of osteoporosis: a systematic review. CMAJ. 2006;175(1):52–59.

3. McClung MR, San Martin J, Miller PD, et al. Opposite bone remodeling effects of teriparatide and alendronate in increasing bone mass [published correction appears in Arch Intern Med. 2005;165(18):2120]. Arch Intern Med. 2005;165(15):1762–1768.

4. Body JJ, Gaich GA, Scheele WH, et al. A randomized double-blind trial to compare the efficacy of teriparatide [recombinant human parathyroid hormone (I-34)] with alendronate in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2002;87(10):4528–4535.

5. Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1–34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001;344(19):1434–1441.

6. Lindsay R, Scheele WH, Neer R, et al. Sustained vertebral fracture risk reduction after withdrawal of teriparatide in postmenopausal women with osteoporosis. Arch Intern Med. 2004;164(18):2024–2030.

7. Saag KG, Zanchetta JR, Devogelaer JP, et al. Effects of teriparatide versus alendronate for treating glucocorticoid-induced osteoporosis: thirty-six month results of a randomized, double-blind, controlled trial. Arthritis Rheum. 2009;60(11):3346–3355.

8. Langdahl BL, Rajzbaum G, Jakob F, et al. Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide: 18-month data from the European Forsteo Observational Study (EFOS). Calcif Tissue Int. 2009;85(6):484–493.

9. American College of Obstetricians and Gynecologists, Women's Health Care Physicians. ACOG practice bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 50, January 2003. Obstet Gynecol. 2004;103(1):203–216.

10. Qaseem A, Snow V, Shekelle P, et al. Pharmacologic treatment of low bone density or osteoporosis to prevent fractures: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2008;149(6):404–415.

11. National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2010. http://www.nof.org/sites/default/files/pdfs/NOF_ClinicianGuide2009_v7.pdf. Accessed February 16, 2011.

Clinical Inquiries provides answers to questions submitted by practicing family physicians to the Family Physicians Inquiries Network (FPIN). Members of the network select questions based on their relevance to family medicine. Answers are drawn from an approved set of evidence-based resources and undergo peer review. The strength of recommendations and the level of evidence for individual studies are rated using criteria developed by the Evidence-Based Medicine Working Group (http://www.cebm.net/?o=1025).

The complete database of evidence-based questions and answers is copyrighted by FPIN. If interested in submitting questions or writing answers for this series, go to http://www.fpin.org or email: questions@fpin.org.

A collection of FPIN's Clinical Inquiries published in AFP is available at http://www.aafp.org/afp/fpin.


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