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CTAP101 Capsules for Secondary Hyperparathyroidism

Phase 1
Waitlist Available
Research Sponsored by OPKO Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This is an open-label exploratory study of CTAP101 Capsules in patients with bone metastases arising from either breast or prostate cancer, who are taking anti-resorptive therapy.

Eligible Conditions
  • Secondary Hyperparathyroidism
  • Hypocalcemia
  • Prostate Cancer
  • Breast Cancer
  • Hyperparathyroidism
  • Bone Cancer
  • Bone Tumors
  • Low Calcium

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability of CTAP101

Side effects data

From 2015 Phase 3 trial • 298 Patients • NCT02282813
10%
Hyperphosphatemia
7%
Hypoglycaemia
7%
Hyperkalaemia
7%
Cough
7%
Hypertension
7%
Oedema
7%
Blood creatinine increased
5%
Anaemia
5%
Nausea
2%
Cardiac failure congestive
2%
Diarrhoea
2%
Urinary tract infection
2%
Cellulitis
2%
Blood creatinine phosphokinase MB increased
2%
Renal failure chronic
2%
Hypertensive crisis
2%
Fatigue
2%
Urinary tract obstruction
2%
Gout
2%
Osteoarthritis
2%
Upper gastrointestinal haemorrhage
2%
Encephalopathy
2%
Hypoglcaemic seizure
2%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive
CTAP101 Capsules (Not Randomized; 12 Mos Treatment)
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CTAP101 CapsulesExperimental Treatment1 Intervention
CTAP101 Capsules daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calcifediol
FDA approved

Find a Location

Who is running the clinical trial?

OPKO Health, Inc.Lead Sponsor
47 Previous Clinical Trials
5,311 Total Patients Enrolled
~3 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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