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Musculoskeletal Health

Musculoskeletal Health

Research

Clinical Trials

Current Open Trials

Amgen 162

A Phase 3 Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

Glucocorticoid medications are used to help control many chronic inflammatory conditions, but can have a negative effect on bone tissue that can lead to bone loss—a condition called glucocorticoid-induced osteoporosis (GIOP). If you are taking a glucocorticoid medication such as prednisone or cortisone, you may be eligible to participate in this trial.

The purpose of this study is to find out if a drug called denosumab is safe and effective in people who have osteoporosis or are at risk of developing osteoporosis as a result of taking glucocorticoids. The primary objective of this trial is to evaluate the effectiveness and safety of an FDA approved drug, denosumab, compared to another FDA approved drug, risedronate.

Denosumab is a fully human monoclonal antibody designed to target a protein that acts as the primary signal for bone removal and overwhelms the body’s natural defenses against bone destruction, whereas risedronate is a bisphosphonate that strengthens bone by inhibiting bone removal by osteoclast.

Eligibility Criteria:

  1. Male or Female aged 18 years or older
  2. Taking 7.5 mg or more of glucocorticoid therapy and are expected to continue receiving it for at least 6 months
  3. Have not used denosumab for osteoporosis at any time in the past

Treatment Protocol:

Subject will be randomly assigned to have a denosumab injection every 6 months and an oral placebo for risedronate daily for 24 months or oral risedronate daily and a placebo of the denosumab  injection every 6 months for 24 months.

If selected to participate in the study you will need to visit our clinic 7 times over the next 6 months, then once every 6 months for 3 visits until month 24.

Length of Study: 2 years

 

Amgen 785

A Phase 3 Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

UC Davis researchers are looking for women with postmenopausal osteoporosis.

The purpose of the study is to learn more about the drug Romosozumab in women with postmenopausal osteoporosis.  This study will see if Romosozumab prevents fractures of the bone and whether it causes any side effects.

Romosozumab is a monoclonal antibody delivered via injection that is designed to increase bone formation by inhibiting a protein associated with bone loss.

You will also be provided with calcium and vitamin D supplements for the duration of the study.

Eligibility Criteria:

  1. Have postmenopausal osteoporosis
  2. Are 55 to 90 years old
  3. Have not had a hip fracture
  4. Are not taking any medication for osteoporosis other than calcium and vitamin D

Treatment Protocol:

Subject will receive either Romosozumab by subcutaneous injection every month or an identical appearing placebo by subcutaneous injection every month for the duration of 11 months.

For the second year of the study, all subjects will be treated with a Denosumab injection at month 12 and month 18.

If selected to participate in the study you will need to visit our clinic every month for one year and then 4 visits during the second year.

Length of Study: 2 years

 

Xoma

This study is closed to enrollment

A Phase 2 Proof-of-concept Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand

The primary objective of this trial is to find out more about a clinical trial drug called Gevokizumab.

Gevokizumab is a monoclonal antibody meant to limit the action of specific proteins in body that release and cause inflammation.

The purpose of this study is to determine what side effects the drug may cause, and whether the drug is useful to treat and help relieve the signs and symptoms of Erosive Osteo-Arthritis of the Hand.

Become a Participant

To learn about how to participate in a clinical trial, please contact us at:

UC Davis Center for Musculoskeletal Health
4625 2nd Ave., Suite 1002
Sacramento CA 95817
Telephone: 916-734-3011
Fax: 916-734-0901
Email: CMHClinicalTrials@ucdmc.ucdavis.edu

 

Past Trials and Findings

Knee Osteoarthritis Tanezumab

The primary objective of this trial was to evaluate the effectiveness and safety of an investigational new drug called Tanezumab and whether it helps relieve the signs and symptoms of knee osteoarthritis.  Tanezumab is an antibody.  An antibody is a type of protein that is produced by the immune system to help protect the body against foreign compounds.  Tanezumab acts against another protein, called human nerve growth factor (NGF).  NGF is a natural compound that’s made by the body and is involved in causing a person to feel pain.  It is thought that the binding of tanezumab to NGF can block NGF activity, reducing the subject’s pain.

http://www.ucdmc.ucdavis.edu/publish/news/newsroom/4365