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Parathyroid hormone

Generic Name
Parathyroid hormone
Brand Names
Natpara, Natpar
Drug Type
Biotech
CAS Number
9002-64-6
Unique Ingredient Identifier
N19A0T0E5J
Background

Parathyroid hormone (PTH) is a single-chain polypeptide composed of 84 amino acids. Available as Preotact, it is an identical form of human recombinant hormome which produced as a fusion protein undergoeing post-translational processing involving the cleavage of the OmpA leader sequence, leaving the mature protein as a single-chain 84 amino-acids polypeptide (9.4 kDa).

Preotact is used in the treatment of osteoporosis in postmenopausal women at high risk of osteoporotic fractures and is marketed in Europe by Nycomed. Preos is a registered trade mark owned by NPS Pharmaceuticals, Inc. The name Preos and the New Drug Application is pending approval by the U.S. Food and Drug Administration (FDA).

Indication

For use/treatment in osteoporosis.

Associated Conditions
Hypocalcemia, Hypoparathyroidism

Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women

Phase 2
Completed
Conditions
Postmenopausal Osteoporosis
Interventions
First Posted Date
2011-03-23
Last Posted Date
2013-03-01
Lead Sponsor
Unigene Laboratories Inc.
Target Recruit Count
97
Registration Number
NCT01321723
Locations
🇪🇪

CCBR, Tallinn, Estonia

A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)

Phase 3
Completed
Conditions
Hypoparathyroidism
Interventions
First Posted Date
2011-02-16
Last Posted Date
2021-05-25
Lead Sponsor
Shire
Target Recruit Count
51
Registration Number
NCT01297309
Locations
🇺🇸

Michigan Bone & Mineral Clinic PC, Detroit, Michigan, United States

🇺🇸

Mayo Clinic Rochester, Rochester, Minnesota, United States

🇺🇸

The Vancouver Clinic, Vancouver, Washington, United States

and more 11 locations

Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)

Phase 3
Completed
Conditions
Hypoparathyroidism
Interventions
First Posted Date
2010-12-29
Last Posted Date
2021-06-11
Lead Sponsor
Shire
Target Recruit Count
42
Registration Number
NCT01268098
Locations
🇺🇸

University of Chicago Medical Center, Chicago, Illinois, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Michigan Bone & Mineral Clinic PC, Detroit, Michigan, United States

and more 9 locations

HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism

Phase 3
Completed
Conditions
Hypoparathyroidism
Interventions
First Posted Date
2010-09-13
Last Posted Date
2024-07-05
Lead Sponsor
Columbia University
Target Recruit Count
62
Registration Number
NCT01199614
Locations
🇺🇸

Columbia University Medical Center, New York, New York, United States

Use of NPSP558 in the Treatment of Hypoparathyroidism

Phase 3
Completed
Conditions
Hypoparathyroidism
Interventions
Drug: Placebo
First Posted Date
2008-08-12
Last Posted Date
2021-06-03
Lead Sponsor
Shire
Target Recruit Count
124
Registration Number
NCT00732615
Locations
🇺🇸

Mayo Clinic-Scottsdale, Scottsdale, Arizona, United States

🇺🇸

Advance Medical Research LLC, Lakewood, California, United States

🇺🇸

Diabetes Associates, Orange, California, United States

and more 28 locations

PTH & Ibandronate Combination Study (PICS)

Phase 2
Completed
Conditions
Osteoporosis
Interventions
Other: Placebo injection
Other: Placebo pills
First Posted Date
2008-05-23
Last Posted Date
2013-11-05
Lead Sponsor
University of California, San Francisco
Target Recruit Count
44
Registration Number
NCT00683163
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

A Safety and Efficacy Study of a Topical Gel for the Treatment of Mild to Moderate Psoriasis

Phase 2
Completed
Conditions
Psoriasis Vulgaris
Interventions
First Posted Date
2008-01-14
Last Posted Date
2008-08-19
Lead Sponsor
Manhattan Pharmaceuticals
Target Recruit Count
61
Registration Number
NCT00593177
Locations
🇺🇸

Therapeutics Clinical Research, San Diego, California, United States

🇺🇸

Minnesota Clinical Study Center, Fridley, Minnesota, United States

🇺🇸

Advanced Dermatology and Cosmetic Surgery, Ormond Beach, Florida, United States

and more 1 locations

Bone Properties in Hypoparathyroidism: Effects of PTH

Phase 2
Completed
Conditions
Hypoparathyroidism
Interventions
First Posted Date
2007-05-15
Last Posted Date
2015-07-16
Lead Sponsor
John P. Bilezikian
Target Recruit Count
68
Registration Number
NCT00473265
Locations
🇺🇸

Columbia University, New York, New York, United States

Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use

Phase 4
Completed
Conditions
Osteoporosis
Interventions
First Posted Date
2005-09-22
Last Posted Date
2015-06-25
Lead Sponsor
University of California, Davis
Target Recruit Count
60
Registration Number
NCT00221299
Locations
🇺🇸

UC Davis General Medicine Research Clinic, Sacramento, California, United States

Open Label Extension

Phase 3
Completed
Conditions
Osteoporosis
First Posted Date
2005-09-15
Last Posted Date
2021-05-17
Lead Sponsor
Shire
Target Recruit Count
91
Registration Number
NCT00172120
Locations
🇺🇸

'The University of Chicago, Chicago, Illinois, United States

🇺🇸

'Rapid City Medical Center, Rapid City, South Dakota, United States

🇦🇷

'IDIM, Buenos Aires, BUE, Argentina

and more 8 locations
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