Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women.
BACKGROUND
Treatment of osteoporosis with an anabolic agent, teriparatide [human PTH 1-34 (TPTD)], is effective in reducing incident fractures, but patient resistance to daily sc injections has limited its use. A novel transdermal patch, providing a rapid, pulse delivery of TPTD, may provide a desirable alternative.


OBJECTIVE
The aim of the study was to determine the safety and efficacy of a novel transdermal TPTD patch compared to placebo patch and sc TPTD 20-microg injection in postmenopausal women with osteoporosis.


METHODS
Our study consisted of 6-month, randomized, placebo-controlled, positive control, multidose daily administration.


METHODS
We enrolled 165 postmenopausal women (mean age, 64 yr) with osteoporosis.


METHODS
A TPTD patch with a 20-, 30-, or 40-microg dose or a placebo patch was self-administered daily for 30-min wear time, or 20 microg of TPTD was injected daily.


RESULTS
The primary efficacy measure was mean percentage change in lumbar spine bone mineral density (BMD) from baseline at 6 months.


RESULTS
TPTD delivered by transdermal patch significantly increased lumbar spine BMD vs. placebo patch in a dose-dependent manner at 6 months (P < 0.001). TPTD 40-microg patch increased total hip BMD compared to both placebo patch and TPTD injection (P < 0.05). Bone turnover markers (procollagen type I N-terminal propeptide and C-terminal cross-linked telopeptide of type I collagen) increased from baseline in a dose-dependent manner in all treatment groups and were all significantly different from placebo patch (P < 0.001). All treatments were well tolerated, and no prolonged hypercalcemia was observed.


CONCLUSIONS
Transdermal patch delivery of TPTD in postmenopausal women with osteoporosis for 6 months is safe and effective in increasing lumbar spine and total hip BMD.
Regional Bone Center, Helen Hayes Hospital, West Haverstraw, New York, New York 10993, USA. cosmanf@helenhayeshosp.com
Felicia
F
Cosman
Nancy E
NE
Lane
Michael A
MA
Bolognese
Jose R
JR
Zanchetta
Pedro A
PA
Garcia-Hernandez
Karen
K
Sees
James A
JA
Matriano
Kim
K
Gaumer
Peter E
PE
Daddona
D000279:Administration, Cutaneous; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D010919:Placebos; D017698:Postmenopause / Q000187:drug effects; D019379:Teriparatide / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics; D016896:Treatment Outcome
D050071:Bone Density Conservation Agents; D010919:Placebos; D019379:Teriparatide