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Romosozumab for Osteoporosis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
UPMC Senior Communities, Pittsburgh, PAOsteoporosis+2 MoreRomosozumab - Drug
Eligibility
65+
Female
What conditions do you have?
Select

Study Summary

This trial will test if a yearly injection of romosozumab, followed by an infusion of zoledronic acid, can help treat and prevent bone loss in older women with osteoporosis who live in long-term care facilities.

Eligible Conditions
  • Osteoporosis
  • Osteoporotic Fractures
  • Postmenopausal Osteoporosis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

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Alendronate 70Mg Tab
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alendronate
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Denosumab 60 MG/ML Prefilled Syringe [Prolia]

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 24 months

24 months
Bone Mineral Density of the spine
Bone Mineral Density of the total hip

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

3
Alendronate 70Mg Tab
2
alendronate
2
Denosumab 60 MG/ML Prefilled Syringe [Prolia]

Side Effects for

Romosozumab 210 mg
21%Nasopharyngitis
9%Hypertension
9%Back pain
6%Constipation
6%Headache
6%Arthralgia
5%Procedural pain
2%Myalgia
2%Muscle spasms
1%Anaemia postoperative
1%Death
1%Implant site haematoma
1%Cardiac failure
1%Myocardial ischaemia
1%Atrial flutter
1%Angina unstable
1%Coronary artery stenosis
1%Osteoarthritis
1%Cardio-respiratory arrest
1%Wolff-Parkinson-White syndrome
1%Cholecystitis
1%Subdural haematoma
1%Thoracic vertebral fracture
1%Non-cardiac chest pain
1%Device related infection
1%Appendicitis
1%Urinary tract infection
1%Rib fracture
1%Gastrooesophageal reflux disease
1%Appendicitis perforated
1%Basal cell carcinoma
1%Cerebral ischaemia
1%Pneumonia
1%Laceration
1%Carotid artery stenosis
1%Cerebrovascular accident
1%Escherichia sepsis
1%Vascular encephalopathy
1%Depressed mood
1%Carotid arteriosclerosis
1%Oropharyngeal cancer
1%Benign prostatic hyperplasia
1%Haemorrhagic stroke
1%Depression
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT02186171) in the Romosozumab 210 mg ARM group. Side effects include: Nasopharyngitis with 21%, Hypertension with 9%, Back pain with 9%, Constipation with 6%, Headache with 6%.

Trial Design

2 Treatment Groups

Romosozumab, then Zoledronic Acid
1 of 2
Placebo, then Zoledronic Acid
1 of 2

Experimental Treatment

Non-Treatment Group

200 Total Participants · 2 Treatment Groups

Primary Treatment: Romosozumab · Has Placebo Group · Phase 4

Romosozumab, then Zoledronic AcidExperimental Group · 3 Interventions: Zoledronic acid, Romosozumab, Calcium and Vitamin D · Intervention Types: Drug, Drug, DietarySupplement
Placebo, then Zoledronic AcidPlaceboComparator Group · 3 Interventions: Zoledronic acid, Placebo, Calcium and Vitamin D · Intervention Types: Drug, Drug, DietarySupplement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zoledronic acid
FDA approved
Romosozumab
FDA approved
Calcium and Vitamin D
2018
Completed Phase 3
~260

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Susan L. GreenspanLead Sponsor
4 Previous Clinical Trials
633 Total Patients Enrolled
4 Trials studying Osteoporosis
633 Patients Enrolled for Osteoporosis
National Institutes of Health (NIH)NIH
2,472 Previous Clinical Trials
24,590,962 Total Patients Enrolled
10 Trials studying Osteoporosis
2,029 Patients Enrolled for Osteoporosis
National Institute on Aging (NIA)NIH
1,449 Previous Clinical Trials
4,279,340 Total Patients Enrolled
22 Trials studying Osteoporosis
12,067 Patients Enrolled for Osteoporosis
Susan L Greenspan, MDPrincipal InvestigatorUniversity of Pittsburgh
5 Previous Clinical Trials
899 Total Patients Enrolled
5 Trials studying Osteoporosis
899 Patients Enrolled for Osteoporosis

Eligibility Criteria

Age 65+ · Female Participants · 1 Total Inclusion Criteria

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References

Frequently Asked Questions

What potential health risks are associated with Romosozumab treatment?

"There is evidence for Romosozumab's safety, thus it has been given a score of 3. This treatment has already cleared Phase 4 trials and can be prescribed to patients in need." - Anonymous Online Contributor

Unverified Answer

Have previous investigations into Romosozumab been conducted?

"Currently, there are 46 active studies concerning Romosozumab with 10 trials in the third phase. The primary site for these clinical tests is Douliu, Yunlin County; yet, this medication has been trialled across 751 different locations worldwide." - Anonymous Online Contributor

Unverified Answer

How many patients have been enrolled in this clinical trial thus far?

"Affirmative, the information hosted on clinicaltrials.gov testifies that this experiment is recruiting participants at present. Initially posted on September 15th 2021, it has since been updated as recently as 7/9/2022 and requires 200 volunteers from 1 medical centre to participate." - Anonymous Online Contributor

Unverified Answer

What conditions does Romosozumab typically ameliorate?

"Romosozumab is a therapeutic agent used to combat glucocorticoids. Furthermore, it has been demonstrated to be effective in the treatment of solid tumors, malignant neoplasms, and osteoporosis." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor presently welcoming participants?

"Affirmative. According to clinicaltrials.gov, this experiement is at present recruiting participants after being initially posted on September 15th 2021 and last edited on September 7th 2022. 200 individuals need to be enlisted from a single medical centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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