Daily nasal spray of hPTH(1-34) for 3 months increases bone mass in osteoporotic subjects

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Daily nasal spray of hPTH(1-34) for 3 months increases bone mass in

osteoporotic subjects: a pilot study.

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Matsumoto T, Shiraki M, Hagino H, Iinuma H, Nakamura T.

Osteoporos Int. 2006 Jun 9; [Epub ahead of print]

Department of Medicine and Bioregulatory Sciences, University of Tokushima

Graduate School of Health Biosciences, Tokushima, 770-8503, Japan,

toshimat@....

INTRODUCTION: Although intermittent parathyroid hormone (PTH) injection can

lead to strong anabolic effects on bone, daily subcutaneous injection is a

disadvantage for patient acceptance. We have developed a nasal spray formula

of parathyroid peptide [hPTH(1-34)] with peak serum hPTH(1-34)

concentrations by nasal spray of 1,000 mug similar to those by subcutaneous

injections of 20 mug hPTH(1-34).

METHODS: To determine the clinical efficacy and safety of nasal hPTH(1-34)

spray, a randomized, open-labeled clinical trial was conducted in subjects

with osteoporosis. Ninety osteoporotic subjects age 52-84 years (mean 66.5

years) were randomly assigned to receive either 250 mug (PTH250, n=31), 500

mug (PTH500, n=30), or 1,000 mug (PTH1000, n=29) of daily nasal hPTH(1-34)

spray for 3 months. All received daily supplements of 300 mg calcium and 200

IU vitamin D(3).

RESULTS: Daily nasal hPTH(1-34) spray for 3 months increased lumbar bone

mineral density (L-BMD) in a dose-dependent manner, and the PTH1000 group

showed a 2.4% increase in L-BMD from baseline. Only the 1,000-mug dose

produced consistent and statistically significant changes in markers of bone

turnover; after 3 months, median serum type I procollagen N-propeptide

(PINP) and osteocalcin increased 14.8% and 19.4% from baseline, while

urinary type I collagen N-telopeptide (NTX) decreased 16.4%. Seven subjects

developed transient hypercalcemia at 3 h after nasal hPTH(1-34) spray, but

none of the subjects developed sustained hypercalcemia.

CONCLUSION: These observations demonstrate that nasal hPTH(1-34) spray is

safe and well tolerated and can rapidly increase L-BMD. The results warrant

further studies to examine its long-term efficacy on bone mass and

fractures.

PMID: 16767525 [PubMed - as supplied by publisher]