PTH & Ibandronate Combination Study (PICS)

NCT00683163 | Completed Phase 2 Results DMC

• 1 other identifier: PICS001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The intension is to provide other options for treatment than the current standard 2 year course of drug therapy. These options may lead to treatment where the two years of therapy are spread over several years.

Conditions

Osteoporosis

Keywords

Combination of PTH and ibandronate; Bone marker formation; Postmenopausal; Trabecular spine BMD

Outcome Measures

Primary Outcomes (1)

• P1NP (ng/ml) Change From Baseline.

  After an overnight fast, serum was drawn at baseline and 1, 3, 6, 12, 15, 18 and 24 months. Samples were stored at -70C until batch assayed in a central laboratory. Serum N-propeptide of type I collagen (P1NP) and C-terminal telopeptide of type I collagen (CTX) were measured by electrochemiluminescent immunoassay. Bone-specified alkaline phosphate (BAP) was measured by paramagnetic particle immunoassay. P1NP was the bone turnover marker upon which we based sample size calculations.

  Baseline, 3 months

Secondary Outcomes (1)

• Change From Baseline in Trabecular Spine vBMD

  Baseline, 24 months.

Study Arms (2)

A: 6 months both + 18 months oral only

ACTIVE COMPARATOR

Group A will receive 6 months of monthly oral ibandronate 150 mg, plus daily PTH 1-84, 1.4 mg; followed by 18 months of ibandronate only. Placebo injections will be given months 13-15. Calcium + Vitamin D supplements, plus multivitamins are provided.

Drug: PTH(1-84); Drug: Ibandronate; Other: Placebo injection

B: (3 months injection + 9 months oral) x 2 years

ACTIVE COMPARATOR

Group B will receive 3 months of daily PTH 1-84, 1.4 mg; followed by 9 months of monthly oral ibandronate, 150 mg in year 1. In year 2, the group will receive another 3 months of daily PTH 1-84; followed by 9 months of monthly ibandronate. Placebo monthly pills will be given months 1-3 and months 13-15, and placebo injections will be given months 4-6. Calcium + Vitamin D supplements, plus multivitamins are provided.

Drug: PTH(1-84); Drug: Ibandronate; Other: Placebo injection; Other: Placebo pills

Interventions

PTH(1-84) DRUG

1.4 mg injected subcutaneously (in the abdomen) daily

Also known as: In Europe, PTH(1-84) is marketed as Preotact.

A: 6 months both + 18 months oral only; B: (3 months injection + 9 months oral) x 2 years

Ibandronate DRUG

150mg by mouth once monthly

Also known as: Boniva

A: 6 months both + 18 months oral only; B: (3 months injection + 9 months oral) x 2 years

Placebo injection OTHER

Daily injections as placebo for PTS 1-84

A: 6 months both + 18 months oral only; B: (3 months injection + 9 months oral) x 2 years

Placebo pills OTHER

Monthly pills as placebo for oral ibandronate

B: (3 months injection + 9 months oral) x 2 years

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Aged 55-75 years, inclusive, at randomization
• Postmenopausal for \>= 5 years (no menses for at least 5 years)
• Have an evaluable bone mineral density scan (DXA) at the spine AND at the hip with a T-score \<= -1.5 either at the spine or the femoral neck or total hip OR have a T-score \<= -1.0 with at least one of the following risk factors for fracture: 1)Age \>= 65 years; 2)History of post-menopausal fracture (non-vertebral or vertebral); 3)Maternal history of hip fracture.
• Be willing and able to self-administer daily injections
• Signed written consent form.

You may not qualify if:

• History of more than 12 months of oral bisphosphonate use ever, or any use (\>4 weeks) with the past 12 months. For those with 4 weeks to 12 months of previous use, a 24 month washout is required.
• History of any IV bisphosphonate use.
• History of more than 12 month of PTH use ever, or any use (\>4 weeks) with the past 12 months.
• History of estrogen (oral or patch) more than one month in the last 6 months or for more than 12 months in the last 2 years.
• Have type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C \> 10.0), or currently using insulin.
• Have serum calcium \>10.2 mg/dl.
• Have Vitamin D level \<15 nanograms/ml.
• Have Stage III renal insufficiency where calculated creatinine clearance \< 40 ml/min by MDRD.
• Have any history of kidney stones in the last 10 years.
• Have any history of hypercalcuria or currently have urine calcium \>300 mg/24 hours.
• Have any history of hypercalcemia.
• Have any history of sarcoidosis.
• Have any history of hyperparathyroidism.
• Have any history of active or treated tuberculosis or other granulomatous disorders.
• History of breast cancer, melanoma or hematologic malignancy which has required treatment within the last 10 years.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (3)

• Li X, Kuo D, Schafer AL, Porzig A, Link TM, Black D, Schwartz AV. Quantification of vertebral bone marrow fat content using 3 Tesla MR spectroscopy: reproducibility, vertebral variation, and applications in osteoporosis. J Magn Reson Imaging. 2011 Apr;33(4):974-9. doi: 10.1002/jmri.22489.

  PMID: 21448966 BACKGROUND

• Schafer AL, Burghardt AJ, Sellmeyer DE, Palermo L, Shoback DM, Majumdar S, Black DM. Postmenopausal women treated with combination parathyroid hormone (1-84) and ibandronate demonstrate different microstructural changes at the radius vs. tibia: the PTH and Ibandronate Combination Study (PICS). Osteoporos Int. 2013 Oct;24(10):2591-601. doi: 10.1007/s00198-013-2349-y. Epub 2013 Apr 16.

  PMID: 23589163 RESULT

• Schafer AL, Sellmeyer DE, Palermo L, Hietpas J, Eastell R, Shoback DM, Black DM. Six months of parathyroid Hormone (1-84) administered concurrently versus sequentially with monthly ibandronate over two years: the PTH and ibandronate combination study (PICS) randomized trial. J Clin Endocrinol Metab. 2012 Oct;97(10):3522-9. doi: 10.1210/jc.2012-1844. Epub 2012 Jul 12.

  PMID: 22791766 RESULT

MeSH Terms

Conditions

Osteoporosis

Interventions

Parathyroid Hormone; Ibandronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Dr. Dennis Black
• Organization: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

dblack@psg.ucsf.edu

415-514-8159

Study Officials

• Dennis M. Black, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 23, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 5, 2013
• Results First Posted: November 5, 2013

Record last verified: 2013-08

Locations

US (1)