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A Comparison of PF708 and Forteo in Osteoporosis Patients

Sponsor
Pfenex, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT03002428
Collaborator
(none)
181
Enrollment
26
Locations
2
Arms
17
Actual Duration (Months)
7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis.

Condition or Disease Intervention/Treatment Phase
  • Drug: Teriparatide (PF708)
  • Drug: Teriparatide (Forteo)
 Phase 3

Detailed Description

This is a randomized, multi-center study conducted in the United States. Men and women with osteoporosis will be enrolled in a parallel-group, open-label study design to compare the effects of PF708 and Forteo after 24 weeks of treatment. Half of the subjects will be randomized to receive PF708, and the other half will be randomized to receive Forteo.

Study Design

Study Type:
Interventional
Actual Enrollment :
181 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Study Comparing the Effects of PF708 and Forteo in Patients With Osteoporosis
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Teriparatide (PF708)

PF708 20 mcg once-daily subcutaneous injection for 24 weeks

Drug: Teriparatide (PF708)
Subcutaneous injection
Active Comparator: Teriparatide (Forteo)

Forteo 20 mcg once-daily subcutaneous injection for 24 weeks

Drug: Teriparatide (Forteo)
Subcutaneous injection

Outcome Measures

Primary Outcome Measures

  1. Blood levels of anti-drug antibody (ADA) against teriparatide [24 weeks]

Secondary Outcome Measures

  1. Mean percentage change in lumbar-spine bone mineral density (BMD) [24 weeks]

  2. Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP) [24 weeks]

  3. Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX) [24 weeks]

  4. Plasma maximum concentration (Cmax) of teriparatide [4 hours]

  5. Plasma area-under-the-curve (AUC) of teriparatide [4 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • If female, ≥5 years postmenopausal at the time of screening, with a DXA-derived BMD value at least 1 standard deviation (SD) below the average of young, healthy women

  • If male, has a DXA-derived BMD value at least 2 SD below the average of young, healthy men

  • Able to use the pen injection device correctly

  • Able to understand and sign the written Informed Consent Form (ICF)

Exclusion Criteria:

  • Treatment with oral bisphosphonates (once daily or once weekly) within 6 months of screening

  • Any current or prior human PTH-derived products (e.g., Forteo, Teribone, Natpara), including for investigational purposes

  • Immobility due to severe or chronically disabling conditions (e.g., stroke, Parkinson's disease, multiple sclerosis)

  • History of metabolic bone diseases other than osteoporosis

  • History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured)

  • History of Paget's disease of bone

  • History of prior external beam or implant radiation therapy involving the skeleton

  • Active urolithiasis or primary hyperparathyroidism

Contacts and Locations

Locations

Site City State Country Postal Code
1 Radiant Research Birmingham Alabama United States 35211
2 The Orthopaedic Group Mobile Alabama United States 36608
3 Radiant Research Chandler Arizona United States 85224
4 Radiant Research Mesa Arizona United States 85213
5 SunValley Arthritis Center Peoria Arizona United States 85381
6 Radiant Research Phoenix Arizona United States 85020
7 Radiant Research Colorado Springs Colorado United States 80909
8 OB-GYN Associates of Mid-Florida Leesburg Florida United States 34748
9 Atlanta Research Center Atlanta Georgia United States 30319
10 Radiant Research Chicago Illinois United States 60602
11 Radiant Research Bridgeton Missouri United States 63044
12 Radiant Research Papillion Nebraska United States 68046
13 Radiant Research Henderson Nevada United States 89074
14 Radiant Research Las Vegas Nevada United States 89128
15 New Mexico Clinical Research & Osteoporosis Center Albuquerque New Mexico United States 87106
16 Lillestol Research Fargo North Dakota United States 58103
17 Radiant Research Akron Ohio United States 44311
18 Radiant Research Cincinnati Ohio United States 45236
19 Altoona Center for Clinical Research Duncansville Pennsylvania United States 16635
20 Pennsylvania Regional Center for Arthritis & Osteoporosis Research Wyomissing Pennsylvania United States 19610
21 Radiant Research Dallas Texas United States 75231
22 Radiant Research Plano Texas United States 75093
23 Radiant Research San Antonio Texas United States 78229
24 Radiant Research San Antonio Texas United States 78240
25 Spectrum Medical Danville Virginia United States 24541
26 Radiant Research Puyallup Washington United States 98372

Sponsors and Collaborators

  • Pfenex, Inc

Investigators

  • Study Director: Hubert C Chen, MD, Pfenex, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pfenex, Inc
ClinicalTrials.gov Identifier:
NCT03002428
Other Study ID Numbers:
  • PF708-301
First Posted:
Dec 23, 2016
Last Update Posted:
May 23, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Osteoporosis
Teriparatide

Study Results

No Results Posted as of May 23, 2018